TOTAL IRON FOR MANUAL/AUTOMATED— 510(k) K902877

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K902877 for TOTAL IRON FOR MANUAL/AUTOMATED, Substantially Equivalent on 1990-07-27. Applicant: Catachem, Inc.. Device class: 1.

Clearance details

Applicant: Catachem, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1990-07-02
Decision date: 1990-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, CT, US

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