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FDA 510(k)

ANTIBODY TO RUBELLA VIRUS

K-Number: K792635 · 1980-03-19

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1980-03-19
Product CodeGOK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIBODY TO RUBELLA VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K792635. The device is classified under product code GOK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIBODY TO RUBELLA VIRUS?

ANTIBODY TO RUBELLA VIRUS is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K792635.

When did ANTIBODY TO RUBELLA VIRUS receive FDA 510(k) clearance?

ANTIBODY TO RUBELLA VIRUS received FDA 510(k) clearance on 1980-03-19, under 510(k) number K792635.

Who is the listed applicant for ANTIBODY TO RUBELLA VIRUS?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIBODY TO RUBELLA VIRUS?

The FDA product code for ANTIBODY TO RUBELLA VIRUS is GOK.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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K873925VIRGO(TM) MEASLES IGG ELISAK873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISA

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Related Devices (Code: GOK)

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K832228RUBASCAN LATEX CARD TESTBd Becton Dickinson Vacutainer Systems PreanalyticK810835RUBAZYME - MAbbott LaboratoriesK792133RUBELISA TEST KITMicrobiological Assoc.K790122RUBANONOrganon, Inc.K781638RUBINDEX*DIRECT SYSTEMOrtho Diagnostics, Inc.K781392CYTOMEGILISH TEST KITMicrobiological Assoc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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