STACLOT(R) PNP TEST KIT— 510(k) K924370

Name: FDA 510(k) clearance K924370
Creator: U.S. Food and Drug Administration
Published: 1993-08-09

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K924370 for STACLOT(R) PNP TEST KIT, Substantially Equivalent on 1993-08-09. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1992-08-28
Decision date: 1993-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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