SERO/TEX MONO TEST

System, Test, Infectious Mononucleosis

TEXAS IMMUNOLOGY, INC.

The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Sero/tex Mono Test.

Pre-market Notification Details

Device IDK821386
510k NumberK821386
Device Name:SERO/TEX MONO TEST
ClassificationSystem, Test, Infectious Mononucleosis
Applicant TEXAS IMMUNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-10
Decision Date1982-07-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816057021611 K821386 000
00816057020324 K821386 000
00816057020317 K821386 000
00816057020300 K821386 000
00816057020294 K821386 000
00816057020287 K821386 000
00816057020270 K821386 000
00816057020263 K821386 000
20885380114363 K821386 000

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