Clarity Diagnostics, LLC
⚠️ Moderate Risk
FEI: 3004043187 • Boca Raton, FL • UNITED STATES
FEI Number
3004043187
Location
Boca Raton, FL
Country
UNITED STATESAddress
1060 Holland Dr Ste B, , Boca Raton, FL, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2007 | 81KHEREAGENT, OCCULT BLOOD | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/7/2007 | 75JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/7/2007 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/7/2007 | 83GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/7/2007 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/7/2007 | 75JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Clarity Diagnostics, LLC's FDA import refusal history?
Clarity Diagnostics, LLC (FEI: 3004043187) has 6 FDA import refusal record(s) in our database, spanning from 11/7/2007 to 11/7/2007.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Clarity Diagnostics, LLC's FEI number is 3004043187.
What types of violations has Clarity Diagnostics, LLC received?
Clarity Diagnostics, LLC has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Clarity Diagnostics, LLC come from?
All FDA import refusal data for Clarity Diagnostics, LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.