ASSERACHROM FPA KIT— 510(k) K854384

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K854384 for ASSERACHROM FPA KIT, Substantially Equivalent on 1986-02-04. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code DAN
Device class: Class 2
Regulation: 21 CFR 866.5350
Advisory panel: Immunology
Date received: 1985-10-30
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAN

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