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FDA 510(k)

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)

K-Number: K893465 · 1989-07-25

ApplicantImmuno Concepts, Inc.
Decision Date1989-07-25
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893465. 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 ANTIBODY TEST (INDIRECT FLUORESCENT TEST)?

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K893465.

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

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893465.

Who is the listed applicant for CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)?

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

What is the FDA product code for CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)?

The FDA product code for CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) is LKQ.

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Other records listing Immuno Concepts, 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.

K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GK013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-ROK972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

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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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