CREATININE-S ASSAY— 510(k) K934587

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K934587 for CREATININE-S ASSAY, Substantially Equivalent on 1994-03-11. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1993-09-23
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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