U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL

Enzyme Controls (assayed And Unassayed)

U. S. DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for U.s. Diagnostics Liquid Ck Isoenzyme Control.

Pre-market Notification Details

Device IDK870738
510k NumberK870738
Device Name:U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
ContactRoy E Speck
CorrespondentRoy E Speck
U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-25
Decision Date1987-04-13

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