Cleared Traditional

K792635 - ANTIBODY TO RUBELLA VIRUS

K792635 is the FDA 510(k) clearance for ANTIBODY TO RUBELLA VIRUS by Electro-Nucleonics Laboratories, Inc.. It is a Class 2 Microbiology device (product code GOK) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K792635 · Electro-Nucleonics Laboratories, Inc. · Microbiology device
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Mar 1980
Decision
91d
Days
Class 2
Risk

K792635 is an FDA 510(k) clearance for the ANTIBODY TO RUBELLA VIRUS. Classified as Antisera, Hai (including Hai Control), Rubella (product code GOK), Class II - Special Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K792635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1979
Decision Date March 19, 1980
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GOK Antisera, Hai (including Hai Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GOK Antisera, Hai (including Hai Control), Rubella

Devices cleared under the same product code (GOK) and FDA review panel - the closest regulatory comparables to K792635.
RUBASCAN LATEX CARD TEST
K832228 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
RUBAZYME - M
K810835 · Abbott Laboratories · May 1981
RUBANON
K790122 · Organon, Inc. · Feb 1979
RUBENOSTICON
K780063 · Organon, Inc. · Jan 1978
HUMAN O BUFFER
K771956 · Flow Laboratories, Inc. · Oct 1977
RUBELLA HEMAGGLUTINATION REAGENT KIT
K771957 · Flow Laboratories, Inc. · Oct 1977