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FDA 510(k)

CMV IGG ELISA TEST

K-Number: K915892 · 1992-02-14

ApplicantGull Laboratories, Inc.
Decision Date1992-02-14
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV IGG ELISA 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 1992-02-14 under 510(k) number K915892. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV IGG ELISA TEST?

CMV IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K915892.

When did CMV IGG ELISA TEST receive FDA 510(k) clearance?

CMV IGG ELISA TEST received FDA 510(k) clearance on 1992-02-14, under 510(k) number K915892.

Who is the listed applicant for CMV IGG ELISA 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 IGG ELISA TEST?

The FDA product code for CMV IGG ELISA TEST is LFZ.

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Other records listing Gull Laboratories, Inc. as applicant

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Related Devices (Code: LFZ)

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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