MODIFIED DSL-2300 ACTH RIA

Radioimmunoassay, Acth

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Modified Dsl-2300 Acth Ria.

Pre-market Notification Details

Device IDK900147
510k NumberK900147
Device Name:MODIFIED DSL-2300 ACTH RIA
ClassificationRadioimmunoassay, Acth
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 CodeCKG  
CFR Regulation Number862.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-11
Decision Date1990-03-01

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