CASCADE M, CAT. NO. 1710

Instrument, Coagulation, Automated

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cascade M, Cat. No. 1710.

Pre-market Notification Details

Device IDK931956
510k NumberK931956
Device Name:CASCADE M, CAT. NO. 1710
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 Received1993-04-20
Decision Date1993-08-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M52517110000 K931956 000

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