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510(k) K910827

ABL520 BLOOD GAS SYSTEM by Radiometer America, Inc. — Product Code GHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
February 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Carboxyhemoglobin
Device Class
Class II
Regulation Number
864.7425
Review Panel
HE
Submission Type

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Other clearances for product code GHS

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  • K770209 — ECOLYZER CARBOXIMETER (March 7, 1977)