C-TERMINAL PTH RIA KIT

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 Kit.

Pre-market Notification Details

Device IDK853784
510k NumberK853784
Device Name:C-TERMINAL PTH RIA KIT
ClassificationRadioimmunoassay, Parathyroid Hormone
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 CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-09
Decision Date1985-10-04

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