CALCIUM, AZO DYE REAGENT— 510(k) K040972

Substantially Equivalent

Genchem, Inc.

FDA 510(k) clearance K040972 for CALCIUM, AZO DYE REAGENT, Substantially Equivalent on 2004-12-27. Applicant: Genchem, Inc.. Device class: 2.

Clearance details

Applicant: Genchem, Inc.
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2004-04-14
Decision date: 2004-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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