ISOCONTROL SERUM CK-MB

Enzyme Controls (assayed And Unassayed)

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Isocontrol Serum Ck-mb.

Pre-market Notification Details

Device IDK850213
510k NumberK850213
Device Name:ISOCONTROL SERUM CK-MB
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactDebra Hofmeister
CorrespondentDebra Hofmeister
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-15
Decision Date1985-03-05

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