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FDA 510(k)

CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT

K-Number: K860279 · 1986-05-13

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1986-05-13
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1986-05-13 under 510(k) number K860279. 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 CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT?

CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1986-05-13. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K860279.

When did CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT receive FDA 510(k) clearance?

CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT received FDA 510(k) clearance on 1986-05-13, under 510(k) number K860279.

Who is the listed applicant for CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT?

The FDA 510(k) record lists Bartels Immunodiagnostic Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT?

The FDA product code for CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT is LIN.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. 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.

K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSK861172ROTAVIRUS LATEX AGGLUTINATION ASSAYK855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTK842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OFK852185RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANTK844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY

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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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