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FDA 510(k)

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA

K-Number: K821542 · 1982-06-03

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1982-06-03
Product CodeLCR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA 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 1982-06-03 under 510(k) number K821542. The device is classified under product code LCR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA?

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K821542.

When did VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA receive FDA 510(k) clearance?

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821542.

Who is the listed applicant for VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA?

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 VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA?

The FDA product code for VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA is LCR.

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

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Related Devices (Code: LCR)

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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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