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510(k) K780173

LYPOPROTEIN CHOLESTEROL TEST KIT by Environmental Chemical Specialties — Product Code JHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
February 2, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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  • K902935 — ROCHE COBAS READY HDL CHOLESTEROL REAGENT (September 27, 1990)
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