Cleared Traditional

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

K801491 · Microanalytic Research, Inc. · Immunology
Aug 1980
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K801491 is an FDA 510(k) clearance for the MRI HCG-BETA RIA KIT CAT. #MR-10100, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980, 48 days after receiving the submission on June 26, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K801491 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1980
Decision Date August 13, 1980
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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