CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323

Calibrator, Multi-analyte Mixture

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323.

Pre-market Notification Details

Device IDK932768
510k NumberK932768
Device Name:CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
ClassificationCalibrator, Multi-analyte Mixture
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 CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-08
Decision Date1993-10-18

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