STAR HCG MONOCLONAL ANTIBODY IMMUNORAD

Visual, Pregnancy Hcg, Prescription Use

SYNCOR INTL. CORP.

The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Star Hcg Monoclonal Antibody Immunorad.

Pre-market Notification Details

Device IDK832796
510k NumberK832796
Device Name:STAR HCG MONOCLONAL ANTIBODY IMMUNORAD
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant SYNCOR INTL. CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-18
Decision Date1984-01-24

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