ACTICHROME ATIII KIT— 510(k) K893608

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K893608 for ACTICHROME ATIII KIT, Substantially Equivalent on 1989-06-23. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1989-05-10
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.