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Siemens Healthcare Diagnostics

⚠️ Moderate Risk

FEI: 3005250747 • Los Angeles, CA • UNITED STATES

FEI

FEI Number

3005250747

📍

Location

Los Angeles, CA

🇺🇸
🏢

Address

5210 Pacific Concourse Dr, , Los Angeles, CA, 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
4/27/2004
Latest Refusal
4/27/2004
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
4/27/2004
82MTGTEST, PROSTATE SPECIFIC ANTIGEN, FREE (NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN COND
508NO 510(K)
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Siemens Healthcare Diagnostics's FDA import refusal history?

Siemens Healthcare Diagnostics (FEI: 3005250747) has 1 FDA import refusal record(s) in our database, spanning from 4/27/2004 to 4/27/2004.

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. Siemens Healthcare Diagnostics's FEI number is 3005250747.

What types of violations has Siemens Healthcare Diagnostics received?

Siemens Healthcare Diagnostics 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 Siemens Healthcare Diagnostics come from?

All FDA import refusal data for Siemens Healthcare Diagnostics 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.