MODEL UCG ASSAY

Visual, Pregnancy Hcg, Prescription Use

MONOCLONAL ANTIBODIES, INC.

The following data is part of a premarket notification filed by Monoclonal Antibodies, Inc. with the FDA for Model Ucg Assay.

Pre-market Notification Details

Device IDK822520
510k NumberK822520
Device Name:MODEL UCG ASSAY
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant MONOCLONAL ANTIBODIES, INC. 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 Received1982-08-23
Decision Date1982-09-28

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