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FDA 510(k)

CMV IGM TEST

K-Number: K831711 · 1983-10-27

ApplicantGull Laboratories, Inc.
Decision Date1983-10-27
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV IGM 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 1983-10-27 under 510(k) number K831711. The device is classified under product code LKQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV IGM TEST?

CMV IGM TEST is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K831711.

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

CMV IGM TEST received FDA 510(k) clearance on 1983-10-27, under 510(k) number K831711.

Who is the listed applicant for CMV IGM 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 IGM TEST?

The FDA product code for CMV IGM TEST is LKQ.

Other records listing Gull Laboratories, Inc. as applicant

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Related Devices (Code: LKQ)

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.

K100433IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,Siemens Healthcare DiagnosticsK972884ACCURUN 146 CMV IGM POSITIVE CONTROLBoston Biomedica, Inc.K933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.K922580BARTELS CYTOMEGALOVIRUS IGM EIABaxter Diagnostics, Inc.K914789ELISA CMV IGMSclavo, Inc.K913080OPUS(R) ANTI CMV-MPb Diagnostics, 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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