CRYPTOSPORIDIUM II

Cryptosporidium Spp.

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Cryptosporidium Ii.

Pre-market Notification Details

Device IDK052932
510k NumberK052932
Device Name:CRYPTOSPORIDIUM II
ClassificationCryptosporidium Spp.
Applicant TECHLAB, INC. 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
ContactDavid M Lyerly
CorrespondentDavid M Lyerly
TECHLAB, INC. 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
Product CodeMHJ  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-19
Decision Date2005-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857031002301 K052932 000
00857031002035 K052932 000

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