SPECIALTY ASSAYED CONTROL-1

Plasma, Control, Normal

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Specialty Assayed Control-1.

Pre-market Notification Details

Device IDK941737
510k NumberK941737
Device Name:SPECIALTY ASSAYED CONTROL-1
ClassificationPlasma, Control, Normal
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 CodeGIZ  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-07
Decision Date1994-10-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855360006243 K941737 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.