CARDIO REP LD CONTROL - CAT NO. 3325

Enzyme Controls (assayed And Unassayed)

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cardio Rep Ld Control - Cat No. 3325.

Pre-market Notification Details

Device IDK950801
510k NumberK950801
Device Name:CARDIO REP LD CONTROL - CAT NO. 3325
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPat Franks
CorrespondentPat Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-21
Decision Date1995-03-30

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