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510(k) K854028

AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER by Verified Medical Research, Inc. — Product Code JIW

K854028 is an FDA 510(k) premarket notification submitted by Verified Medical Research, Inc. for the device "AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1985
Date Received
October 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K880654 — AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (June 7, 1988)
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FDA data resources