DSL 1400

Radioimmunoassay, Estriol

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 1400.

Pre-market Notification Details

Device IDK822314
510k NumberK822314
Device Name:DSL 1400
ClassificationRadioimmunoassay, Estriol
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGI  
CFR Regulation Number862.1265 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-03
Decision Date1982-09-30

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