SICKLE-CHEX SOLUBILITY KIT

Test, Sickle Cell

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Sickle-chex Solubility Kit.

Pre-market Notification Details

Device IDK023656
510k NumberK023656
Device Name:SICKLE-CHEX SOLUBILITY KIT
ClassificationTest, Sickle Cell
Applicant STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista,  NE  68128
ContactCarol Thompson
CorrespondentCarol Thompson
STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista,  NE  68128
Product CodeGHM  
CFR Regulation Number864.7825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-30
Decision Date2002-12-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844509002048 K023656 000
00844509002031 K023656 000
00844509002024 K023656 000

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