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FDA 510(k)

ANTIBODY TO VARICELLA-ZOSTER VIRUS

K-Number: K800787 · 1980-07-14

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1980-07-14
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANTIBODY TO VARICELLA-ZOSTER 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 1980-07-14 under 510(k) number K800787. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIBODY TO VARICELLA-ZOSTER VIRUS?

ANTIBODY TO VARICELLA-ZOSTER VIRUS is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K800787.

When did ANTIBODY TO VARICELLA-ZOSTER VIRUS receive FDA 510(k) clearance?

ANTIBODY TO VARICELLA-ZOSTER VIRUS received FDA 510(k) clearance on 1980-07-14, under 510(k) number K800787.

Who is the listed applicant for ANTIBODY TO VARICELLA-ZOSTER 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 VARICELLA-ZOSTER VIRUS?

The FDA product code for ANTIBODY TO VARICELLA-ZOSTER VIRUS is GGW.

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

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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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