GAS TRAK CONNECT BLOOD GAS CONTROL— 510(k) K914099

Name: FDA 510(k) clearance K914099
Creator: U.S. Food and Drug Administration
Published: 1991-12-18

Substantially Equivalent

Biochemical Sciences, Inc.

FDA 510(k) clearance K914099 for GAS TRAK CONNECT BLOOD GAS CONTROL, Substantially Equivalent on 1991-12-18. Applicant: Biochemical Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Biochemical Sciences, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1991-09-12
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

Download summary PDF View on FDA.gov ↗

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