C-TERMINAL PTH RIA TEST KIT, DSL-1000

Radioimmunoassay, Parathyroid Hormone

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for C-terminal Pth Ria Test Kit, Dsl-1000.

Pre-market Notification Details

Device IDK813203
510k NumberK813203
Device Name:C-TERMINAL PTH RIA TEST KIT, DSL-1000
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-13
Decision Date1981-12-03

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