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FDA 510(k)

VIROGEN CMV ANTIBODY TEST

K-Number: K875101 · 1988-03-01

ApplicantWampole Laboratories
Decision Date1988-03-01
Product CodeLQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIROGEN CMV ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1988-03-01 under 510(k) number K875101. The device is classified under product code LQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIROGEN CMV ANTIBODY TEST?

VIROGEN CMV ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1988-03-01. The listed applicant is Wampole Laboratories. The 510(k) number is K875101.

When did VIROGEN CMV ANTIBODY TEST receive FDA 510(k) clearance?

VIROGEN CMV ANTIBODY TEST received FDA 510(k) clearance on 1988-03-01, under 510(k) number K875101.

Who is the listed applicant for VIROGEN CMV ANTIBODY TEST?

The FDA 510(k) record lists Wampole Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIROGEN CMV ANTIBODY TEST?

The FDA product code for VIROGEN CMV ANTIBODY TEST is LQO.

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Other records listing Wampole Laboratories as applicant

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Related Devices (Code: LQO)

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.

K894712ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATIONGen-Probe, Inc.K873670SNAP CAMPYLOBACTOR DIAGNOSTIC KITMolecular Biosystems, Inc.K863270GENE-TRAK CAMPYLOBACTER ASSAYIntegrated Genetics

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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