SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT— 510(k) K964698

Substantially Equivalent

Andwin Scientific

FDA 510(k) clearance K964698 for SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT, Substantially Equivalent on 1997-03-03. Applicant: Andwin Scientific.

Clearance details

Applicant: Andwin Scientific
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1996-11-22
Decision date: 1997-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

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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.