FLUID SAMPLE RETRIEVAL SYSTEM— 510(k) K030394

Substantially Equivalent

Biomed Personal Metabolic and Nutritional Testing

FDA 510(k) clearance K030394 for FLUID SAMPLE RETRIEVAL SYSTEM, Substantially Equivalent on 2003-10-27. Applicant: Biomed Personal Metabolic and Nutritional Testing.

Clearance details

Applicant: Biomed Personal Metabolic and Nutritional Testing
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2003-02-05
Decision date: 2003-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.