COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER— 510(k) K850139

Name: FDA 510(k) clearance K850139
Creator: U.S. Food and Drug Administration
Published: 1985-04-10

Substantially Equivalent

Rapid Diagnostic Laboratories, Inc.

FDA 510(k) clearance K850139 for COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER, Substantially Equivalent on 1985-04-10. Applicant: Rapid Diagnostic Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Rapid Diagnostic Laboratories, Inc.
Product code: Code KRJ
Device class: Class 2
Regulation: 21 CFR 870.4280
Advisory panel: Cardiovascular
Date received: 1985-01-14
Decision date: 1985-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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