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FDA 510(k)

VIDAS CMV IGM ASSAY

K-Number: K933549 · 1994-08-02

ApplicantBiomerieux Vitek, Inc.
Decision Date1994-08-02
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS CMV IGM ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K933549. 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 VIDAS CMV IGM ASSAY?

VIDAS CMV IGM ASSAY is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K933549.

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

VIDAS CMV IGM ASSAY received FDA 510(k) clearance on 1994-08-02, under 510(k) number K933549.

Who is the listed applicant for VIDAS CMV IGM ASSAY?

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

What is the FDA product code for VIDAS CMV IGM ASSAY?

The FDA product code for VIDAS CMV IGM ASSAY is LKQ.

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Other records listing Biomerieux Vitek, Inc. as applicant

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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

View all 49 devices →

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.K922580BARTELS CYTOMEGALOVIRUS IGM EIABaxter Diagnostics, Inc.K914789ELISA CMV IGMSclavo, Inc.K913080OPUS(R) ANTI CMV-MPb Diagnostics, Inc.K900743CMV-IGM IFA TEST SYSTEMZeus Scientific, 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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