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FDA 510(k)

CMV-EA MAB TEST

K-Number: K912592 · 1991-12-04

ApplicantGull Laboratories, Inc.
Decision Date1991-12-04
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV-EA MAB TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K912592. The device is classified under product code LIN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV-EA MAB TEST?

CMV-EA MAB TEST is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K912592.

When did CMV-EA MAB TEST receive FDA 510(k) clearance?

CMV-EA MAB TEST received FDA 510(k) clearance on 1991-12-04, under 510(k) number K912592.

Who is the listed applicant for CMV-EA MAB TEST?

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

What is the FDA product code for CMV-EA MAB TEST?

The FDA product code for CMV-EA MAB TEST is LIN.

Other records listing Gull Laboratories, Inc. as applicant

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Related Devices (Code: LIN)

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.

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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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