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FDA 510(k)

ABBOTT CMV-M EIA KIT

K-Number: K872881 · 1988-05-13

ApplicantAbbott Laboratories
Decision Date1988-05-13
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT CMV-M EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K872881. 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 ABBOTT CMV-M EIA KIT?

ABBOTT CMV-M EIA KIT is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Abbott Laboratories. The 510(k) number is K872881.

When did ABBOTT CMV-M EIA KIT receive FDA 510(k) clearance?

ABBOTT CMV-M EIA KIT received FDA 510(k) clearance on 1988-05-13, under 510(k) number K872881.

Who is the listed applicant for ABBOTT CMV-M EIA KIT?

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

What is the FDA product code for ABBOTT CMV-M EIA KIT?

The FDA product code for ABBOTT CMV-M EIA KIT is LKQ.

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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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