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Diagnostic Solutions Inc

✅ Low Risk

FEI: 2027242 • Irvine, CA • UNITED STATES

FEI

FEI Number

2027242

📍

Location

Irvine, CA

🇺🇸
🏢

Address

1340 Reynolds Ave Ste 110, , Irvine, CA, United States

Low Risk

FDA Import Risk Assessment

18.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
2/25/2003
Latest Refusal
12/4/2001
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
16.3×10%
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

3412×

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

DateProductViolationsDivision
2/25/2003
83JSWKIT, IDENTIFICATION, GLUCOSE NONFERMENTER
341REGISTERED
New York District Office (NYK-DO)
12/4/2001
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Diagnostic Solutions Inc's FDA import refusal history?

Diagnostic Solutions Inc (FEI: 2027242) has 2 FDA import refusal record(s) in our database, spanning from 12/4/2001 to 2/25/2003.

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. Diagnostic Solutions Inc's FEI number is 2027242.

What types of violations has Diagnostic Solutions Inc received?

Diagnostic Solutions Inc 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 Diagnostic Solutions Inc come from?

All FDA import refusal data for Diagnostic Solutions Inc 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.