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FDA 510(k)

CMV TEST

K-Number: K843138 · 1985-01-29

ApplicantMicrobiological Research Corp.
Decision Date1985-01-29
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV 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 1985-01-29 under 510(k) number K843138. The device is classified under product code LIN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV TEST?

CMV TEST is a medical device that received FDA 510(k) clearance on 1985-01-29. The listed applicant is Microbiological Research Corp.. The 510(k) number is K843138.

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

CMV TEST received FDA 510(k) clearance on 1985-01-29, under 510(k) number K843138.

Who is the listed applicant for CMV 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 CMV TEST?

The FDA product code for CMV TEST is LIN.

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)K860450THE CMV-IGM TEST

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Related Devices (Code: LIN)

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.

K081164D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITDiagnostic Hybrids, Inc.K983762NUCLISENS CMV PP67Organon Teknika Corp.K991650CMV BRITE TURBO KITBiotest Diagnostics Corp.K951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK951550CMV BRITE ANTIGENEMIA TEST KITBiotest Diagnostics Corp.K934798PATHODX CYTOMEGALOVIRUSDiagnostic Products Corp.

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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