CBC PAP TEST KIT— 510(k) K802153

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K802153 for CBC PAP TEST KIT, Substantially Equivalent on 1980-11-12. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1980-09-08
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFH

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K931701 — IMMULITE PAP1994-01-27
K925377 — IMX PAP1993-01-13

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K813493 — ENZYGNOST TM RUBELLA IGM1982-03-04

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