CASCADE 480

Instrument, Coagulation, Automated

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cascade 480.

Pre-market Notification Details

Device IDK921363
510k NumberK921363
Device Name:CASCADE 480
ClassificationInstrument, Coagulation, Automated
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 CodeGKP  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-20
Decision Date1992-06-09

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