ACTIVE CROSSLAPS ELISA

Column Chromatography & Color Development, Hydroxyproline

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Crosslaps Elisa.

Pre-market Notification Details

Device IDK960171
510k NumberK960171
Device Name:ACTIVE CROSSLAPS ELISA
ClassificationColumn Chromatography & Color Development, Hydroxyproline
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohn Willis
CorrespondentJohn Willis
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeJMM  
CFR Regulation Number862.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-03-28
Summary:summary

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