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510(k) K771474

MULTISTAT III X-HBDH TEST by Instrumentation Laboratory CO — Product Code JMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1977
Date Received
August 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device Class
Class I
Regulation Number
862.1380
Review Panel
CH
Submission Type

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Other clearances for product code JMK

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  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
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