CHROM Z-F:VIII, CAT. NO. 5241

Test, Qualitative And Quantitative Factor Deficiency

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Chrom Z-f:viii, Cat. No. 5241.

Pre-market Notification Details

Device IDK952668
510k NumberK952668
Device Name:CHROM Z-F:VIII, CAT. NO. 5241
ClassificationTest, Qualitative And Quantitative Factor Deficiency
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 CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-12
Decision Date1996-02-09

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