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510(k) K843379

VMA ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa) — Product Code CDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1984
Date Received
August 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
Device Class
Class I
Regulation Number
862.1795
Review Panel
CH
Submission Type

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  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)

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