CRYPTO-LEX SYSTEM

Antisera, Latex Agglutination, Cryptococcus Neoformans

TRINITY LABORATORIES, INC.

The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Crypto-lex System.

Pre-market Notification Details

Device IDK930418
510k NumberK930418
Device Name:CRYPTO-LEX SYSTEM
ClassificationAntisera, Latex Agglutination, Cryptococcus Neoformans
Applicant TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh,  NC  27613
ContactBruce A Clinton
CorrespondentBruce A Clinton
TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh,  NC  27613
Product CodeGMD  
CFR Regulation Number866.3165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-26
Decision Date1994-02-17

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