SERO/TEX LE TEST

System, Test, Systemic Lupus Erythematosus

TEXAS IMMUNOLOGY, INC.

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

Pre-market Notification Details

Device IDK821385
510k NumberK821385
Device Name:SERO/TEX LE TEST
ClassificationSystem, Test, Systemic Lupus Erythematosus
Applicant TEXAS IMMUNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHC  
CFR Regulation Number866.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-10
Decision Date1982-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816057021604 K821385 000
00816057020256 K821385 000
00816057020249 K821385 000
00816057020232 K821385 000
00816057020225 K821385 000
00816057020218 K821385 000
00816057020201 K821385 000
00816057020195 K821385 000

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