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FDA 510(k)

IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530

K-Number: K872942 · 1988-01-11

ApplicantClinical Sciences, Inc.
Decision Date1988-01-11
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1988-01-11 under 510(k) number K872942. 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 IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530?

IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 is a medical device that received FDA 510(k) clearance on 1988-01-11. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K872942.

When did IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 receive FDA 510(k) clearance?

IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 received FDA 510(k) clearance on 1988-01-11, under 510(k) number K872942.

Who is the listed applicant for IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530?

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

What is the FDA product code for IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530?

The FDA product code for IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 is LKQ.

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Other records listing Clinical Sciences, Inc. as applicant

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K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITK883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550

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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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