PTT AUTOMATE TEST KIT— 510(k) K861190

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K861190 for PTT AUTOMATE TEST KIT, Substantially Equivalent on 1986-06-23. 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: 1986-03-31
Decision date: 1986-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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