KING DIAGNOSTICS CK REAGENT— 510(k) K931326

Name: FDA 510(k) clearance K931326
Creator: U.S. Food and Drug Administration
Published: 1993-06-15

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K931326 for KING DIAGNOSTICS CK REAGENT, Substantially Equivalent on 1993-06-15. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1993-03-16
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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