DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.— 510(k) K892905

Name: FDA 510(k) clearance K892905
Creator: U.S. Food and Drug Administration
Published: 1989-06-19

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K892905 for DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI., Substantially Equivalent on 1989-06-19. Applicant: Catachem, Inc.. Device class: 2.

Clearance details

Applicant: Catachem, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1989-04-20
Decision date: 1989-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

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