BLOOD KIT, SEXUAL ASSAULT KIT— 510(k) K945245

Substantially Equivalent

Lynn Peavey Co.

FDA 510(k) clearance K945245 for BLOOD KIT, SEXUAL ASSAULT KIT, Substantially Equivalent on 1995-02-01. Applicant: Lynn Peavey Co..

Clearance details

Applicant: Lynn Peavey Co.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1994-10-27
Decision date: 1995-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, 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.