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FDA 510(k)

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT

K-Number: K921616 · 1992-08-11

ApplicantIncstar Corp.
Decision Date1992-08-11
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent for Some Indications

Device Summary

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1992-08-11 under 510(k) number K921616. The device is classified under product code LIN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CMV-VUE(TM) CMV ANTIGEN DETECTION KIT?

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT is a medical device that received FDA 510(k) clearance on 1992-08-11. The listed applicant is Incstar Corp.. The 510(k) number is K921616.

When did CMV-VUE(TM) CMV ANTIGEN DETECTION KIT receive FDA 510(k) clearance?

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT received FDA 510(k) clearance on 1992-08-11, under 510(k) number K921616.

Who is the listed applicant for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT?

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

What is the FDA product code for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT?

The FDA product code for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT is LIN.

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Other records listing Incstar 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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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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