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FDA 510(k)

BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN

K-Number: K904036 · 1990-10-16

ApplicantBaxter Healthcare Corp
Decision Date1990-10-16
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-10-16 under 510(k) number K904036. 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 BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN?

BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN is a medical device that received FDA 510(k) clearance on 1990-10-16. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K904036.

When did BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN receive FDA 510(k) clearance?

BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN received FDA 510(k) clearance on 1990-10-16, under 510(k) number K904036.

Who is the listed applicant for BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN?

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

What is the FDA product code for BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN?

The FDA product code for BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN is LIN.

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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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