Cleared Traditional

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL

K803133 · Microbiological Research Corp. · Microbiology
Jan 1981
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K803133 is an FDA 510(k) clearance for the RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1981, 48 days after receiving the submission on December 12, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K803133 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1980
Decision Date January 29, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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