CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION

Enzyme Controls (assayed And Unassayed)

CLINICAL CONTROLS, INC.

The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Cardiospex(tm) Liquid Ckmb/ld-1 Immunoinhibition.

Pre-market Notification Details

Device IDK946146
510k NumberK946146
Device Name:CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach,  CA  93433
ContactJames F Godfrey
CorrespondentJames F Godfrey
CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach,  CA  93433
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-16
Decision Date1995-01-24

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