CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,

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 Ckmb/myoglobin Mass Measuremeny Control Level 1, 2, 3,.

Pre-market Notification Details

Device IDK944923
510k NumberK944923
Device Name:CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
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 Received1994-10-06
Decision Date1994-11-04

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