DIRECT BILIRUBIN FOR CONTINUOUS FLOW— 510(k) K891240

Name: FDA 510(k) clearance K891240
Creator: U.S. Food and Drug Administration
Published: 1989-05-10

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K891240 for DIRECT BILIRUBIN FOR CONTINUOUS FLOW, Substantially Equivalent on 1989-05-10. 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: 1989-03-07
Decision date: 1989-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

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