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FDA 510(k)

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

K-Number: K893419 · 1989-08-03

ApplicantCoulter Immunology
Decision Date1989-08-03
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Immunology. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K893419. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)?

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Coulter Immunology. The 510(k) number is K893419.

When did COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) receive FDA 510(k) clearance?

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893419.

Who is the listed applicant for COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)?

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

What is the FDA product code for COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)?

The FDA product code for COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) is DEW.

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Other records listing Coulter Immunology 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.

K922744CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1K922745CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1K910473CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITCK911793COULTERCLONEK893852COULTER CLONE T4 MONOCLONAL ANTIBODYK893853COULTER CLONE T8 MONOCLONAL ANTIBODY

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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