MRI HCG-BETA RIA KIT CAT. #MR-10100

Visual, Pregnancy Hcg, Prescription Use

MICROANALYTIC RESEARCH, INC.

The following data is part of a premarket notification filed by Microanalytic Research, Inc. with the FDA for Mri Hcg-beta Ria Kit Cat. #mr-10100.

Pre-market Notification Details

Device IDK801491
510k NumberK801491
Device Name:MRI HCG-BETA RIA KIT CAT. #MR-10100
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant MICROANALYTIC RESEARCH, 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 Received1980-06-26
Decision Date1980-08-13

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