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FDA 510(k)

VIRGO HSV-2 IGG ELISA

K-Number: K883281 · 1989-03-10

ApplicantElectro-Nucleonics, Inc.
Decision Date1989-03-10
Product CodeGQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRGO HSV-2 IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics, Inc.. It received FDA 510(k) clearance on 1989-03-10 under 510(k) number K883281. The device is classified under product code GQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO HSV-2 IGG ELISA?

VIRGO HSV-2 IGG ELISA is a medical device that received FDA 510(k) clearance on 1989-03-10. The listed applicant is Electro-Nucleonics, Inc.. The 510(k) number is K883281.

When did VIRGO HSV-2 IGG ELISA receive FDA 510(k) clearance?

VIRGO HSV-2 IGG ELISA received FDA 510(k) clearance on 1989-03-10, under 510(k) number K883281.

Who is the listed applicant for VIRGO HSV-2 IGG ELISA?

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

What is the FDA product code for VIRGO HSV-2 IGG ELISA?

The FDA product code for VIRGO HSV-2 IGG ELISA is GQO.

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Other records listing Electro-Nucleonics, 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.

K893718DELTATEST (R) LIPASE IIK883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIK883282VIRGO HSV-1 IGG ELISAK883427VIRGO(R) VZV-IGG ELISAK883102VIRGO (R) CMV-IGG ELISAK884784VIRGO(R) MICROWELL ALT ASSAY

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Related Devices (Code: GQO)

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.

K883282VIRGO HSV-1 IGG ELISAElectro-Nucleonics, Inc.K881261BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd.K875366THE DDI SERODOT HERPES IGG TEST KITDisease Detection International, Inc.K871426VIROGEN HSV ANTIBODY TESTArmkel, LLCK861120THE GOLDEN QUAD TEST (HSV)Microbiological Research Corp.K854712VISIBLE-HERPES TM TEST SYSTEMIsolab, Inc.

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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