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FDA 510(k)

CMV BRITE ANTIGENEMIA TEST KIT

K-Number: K951550 · 1996-01-30

ApplicantBiotest Diagnostics Corp.
Decision Date1996-01-30
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV BRITE ANTIGENEMIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biotest Diagnostics Corp.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K951550. 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 BRITE ANTIGENEMIA TEST KIT?

CMV BRITE ANTIGENEMIA TEST KIT is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Biotest Diagnostics Corp.. The 510(k) number is K951550.

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

CMV BRITE ANTIGENEMIA TEST KIT received FDA 510(k) clearance on 1996-01-30, under 510(k) number K951550.

Who is the listed applicant for CMV BRITE ANTIGENEMIA TEST KIT?

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

What is the FDA product code for CMV BRITE ANTIGENEMIA TEST KIT?

The FDA product code for CMV BRITE ANTIGENEMIA TEST KIT is LIN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biotest Diagnostics 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.

K991650CMV BRITE TURBO KITK983842BIOTEST ANTI-EBV RECOMBINANT, EA IGMK983839BIOTEST ANTI-EBV RECOMBINANTK983841BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG

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 DiagnosticsK934798PATHODX CYTOMEGALOVIRUSDiagnostic Products Corp.K921616CMV-VUE(TM) CMV ANTIGEN DETECTION KITIncstar 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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