DSL PROGESTERONE RIA (DSL #3400)

Radioimmunoassay, Progesterone

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Progesterone Ria (dsl #3400).

Pre-market Notification Details

Device IDK854649
510k NumberK854649
Device Name:DSL PROGESTERONE RIA (DSL #3400)
ClassificationRadioimmunoassay, Progesterone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactGopal Savjani
CorrespondentGopal Savjani
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-19
Decision Date1985-12-13

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