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Abbott Point Of Care Inc.

⚠️ Moderate Risk

FEI: 2245578 • Princeton, NJ • UNITED STATES

FEI

FEI Number

2245578

📍

Location

Princeton, NJ

🇺🇸
🏢

Address

400 College Rd E, , Princeton, NJ, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/1/2003
Latest Refusal
4/1/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
4/1/2003
75CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
508NO 510(K)
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Abbott Point Of Care Inc.'s FDA import refusal history?

Abbott Point Of Care Inc. (FEI: 2245578) has 1 FDA import refusal record(s) in our database, spanning from 4/1/2003 to 4/1/2003.

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. Abbott Point Of Care Inc.'s FEI number is 2245578.

What types of violations has Abbott Point Of Care Inc. received?

Abbott Point Of Care 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 Abbott Point Of Care Inc. come from?

All FDA import refusal data for Abbott Point Of Care 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.