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FDA 510(k)

ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS

K-Number: K821249 · 1982-07-30

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1982-07-30
Product CodeGRE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENI ANTIBODY TO MEASLES(RUBEOLA) 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 1982-07-30 under 510(k) number K821249. The device is classified under product code GRE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS?

ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K821249.

When did ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS receive FDA 510(k) clearance?

ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821249.

Who is the listed applicant for ENI ANTIBODY TO MEASLES(RUBEOLA) 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 ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS?

The FDA product code for ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS is GRE.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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: GRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K884004RUBEOLA TESTGull Laboratories, Inc.K853067FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENTIdt, A Division of Whittaker M.A. BioproductsK770687MEASLESVIRUS FLOURE. CONJUGATED ANTISERUMicrobiological 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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