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FDA 510(k)

THE CMV-IGM TEST

K-Number: K860450 · 1986-05-13

ApplicantMicrobiological Research Corp.
Decision Date1986-05-13
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE CMV-IGM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1986-05-13 under 510(k) number K860450. 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 THE CMV-IGM TEST?

THE CMV-IGM TEST is a medical device that received FDA 510(k) clearance on 1986-05-13. The listed applicant is Microbiological Research Corp.. The 510(k) number is K860450.

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

THE CMV-IGM TEST received FDA 510(k) clearance on 1986-05-13, under 510(k) number K860450.

Who is the listed applicant for THE CMV-IGM TEST?

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

What is the FDA product code for THE CMV-IGM TEST?

The FDA product code for THE CMV-IGM TEST is LKQ.

Other records listing Microbiological Research Corp. 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.

K883011MRI NEO-TRYP TRYPSIN RIAK861123THE GOLDEN QUAD TEST (CMV)K861121THE GOLDEN QUAD TEST (EBV)K861122THE GOLDEN QUAD TEST (TOXO)K861120THE GOLDEN QUAD TEST (HSV)K843138CMV TEST

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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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