Cleared Traditional

RUBELLA RQ BIO-ENZABEAD KIT

K821804 · Litton Bionetics · Microbiology
Sep 1982
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K821804 is an FDA 510(k) clearance for the RUBELLA RQ BIO-ENZABEAD KIT, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 89 days after receiving the submission on June 17, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K821804 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1982
Decision Date September 14, 1982
Days to Decision 89 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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