DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)

Radioimmunoassay, 17-hydroxyprogesterone

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active 17a-oh Progesterone Ria (dsl 5000).

Pre-market Notification Details

Device IDK943148
510k NumberK943148
Device Name:DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
ClassificationRadioimmunoassay, 17-hydroxyprogesterone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohnny R Willis
CorrespondentJohnny R Willis
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeJLX  
CFR Regulation Number862.1395 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-30
Decision Date1994-11-10

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