PTH-RIA

Radioimmunoassay, Parathyroid Hormone

SYNCOR INTL. CORP.

The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Pth-ria.

Pre-market Notification Details

Device IDK844735
510k NumberK844735
Device Name:PTH-RIA
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar,  CA  91342
ContactEleanor V Chiu
CorrespondentEleanor V Chiu
SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar,  CA  91342
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-04
Decision Date1985-04-29

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