CHROM Z-HEPARIN, CAT. NO 5242

Assay, Heparin

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Chrom Z-heparin, Cat. No 5242.

Pre-market Notification Details

Device IDK952667
510k NumberK952667
Device Name:CHROM Z-HEPARIN, CAT. NO 5242
ClassificationAssay, Heparin
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 CodeKFF  
CFR Regulation Number864.7525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-12
Decision Date1996-02-14

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