C. DIFF QUIK CHEK COMPLETE

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 Quik Chek Complete.

Pre-market Notification Details

Device IDK082499
510k NumberK082499
Device Name:C. DIFF QUIK CHEK COMPLETE
ClassificationReagents, Clostridium Difficile Toxin
Applicant TECHLAB, INC. 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
ContactCharles Pennington
CorrespondentCharles Pennington
TECHLAB, INC. 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
Product CodeLLH  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-29
Decision Date2009-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002387 K082499 000
00857031002370 K082499 000
00857031002158 K082499 000
00857031002059 K082499 000
00857031002554 K082499 000

Trademark Results [C. DIFF QUIK CHEK COMPLETE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
C. DIFF QUIK CHEK COMPLETE
C. DIFF QUIK CHEK COMPLETE
77466957 3597654 Live/Registered
TechLab, Inc.
2008-05-06

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