ACTH NORMAL RANGE

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 Acth Normal Range.

Pre-market Notification Details

Device IDK842249
510k NumberK842249
Device Name:ACTH NORMAL RANGE
ClassificationRadioimmunoassay, Acth
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCKG  
CFR Regulation Number862.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-06
Decision Date1984-08-15

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