CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS— 510(k) K894389

Name: FDA 510(k) clearance K894389
Creator: U.S. Food and Drug Administration
Published: 1989-10-12

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K894389 for CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS, Substantially Equivalent on 1989-10-12. Applicant: Catachem, Inc.. Device class: 1.

Clearance details

Applicant: Catachem, Inc.
Product code: Code GGX
Device class: Class 1
Regulation: 21 CFR 864.6160
Advisory panel: Hematology
Date received: 1989-07-17
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

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