C. DIFF CHEK - 60

Reagents, Clostridium Difficile Toxin

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Diff Chek - 60.

Pre-market Notification Details

Device IDK030992
510k NumberK030992
Device Name:C. DIFF CHEK - 60
ClassificationReagents, Clostridium Difficile Toxin
Applicant TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg,  VA  24060 -6364
ContactDavid M Lyerly
CorrespondentDavid M Lyerly
TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg,  VA  24060 -6364
Product CodeLLH  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-28
Decision Date2003-07-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002233 K030992 000
00857031002226 K030992 000
00857031002110 K030992 000
00857031002448 K030992 000
00857031002660 K030992 000

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