C. DIFFICILE TOX A/B II

Reagents, Clostridium Difficile Toxin

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Difficile Tox A/b Ii.

Pre-market Notification Details

Device IDK003306
510k NumberK003306
Device Name:C. DIFFICILE TOX A/B II
ClassificationReagents, Clostridium Difficile Toxin
Applicant TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg,  VA  24060
ContactDavid M Lyerly
CorrespondentDavid M Lyerly
TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg,  VA  24060
Product CodeLLH  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-20
Decision Date2000-11-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002424 K003306 000
00857031002103 K003306 000
00857031002219 K003306 000
00857031002431 K003306 000
00857031002646 K003306 000

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