AT-III CALIBRATOR— 510(k) K944279

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K944279 for AT-III CALIBRATOR, Substantially Equivalent on 1995-04-07. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1994-08-30
Decision date: 1995-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parisppany, 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.