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FDA 510(k)

ELISA COMBI-KIT HUMAN IGG SUBCLASSES

K-Number: K911610 · 1991-06-12

ApplicantJanssen Research Foundation
Decision Date1991-06-12
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELISA COMBI-KIT HUMAN IGG SUBCLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Janssen Research Foundation. It received FDA 510(k) clearance on 1991-06-12 under 510(k) number K911610. 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 ELISA COMBI-KIT HUMAN IGG SUBCLASSES?

ELISA COMBI-KIT HUMAN IGG SUBCLASSES is a medical device that received FDA 510(k) clearance on 1991-06-12. The listed applicant is Janssen Research Foundation. The 510(k) number is K911610.

When did ELISA COMBI-KIT HUMAN IGG SUBCLASSES receive FDA 510(k) clearance?

ELISA COMBI-KIT HUMAN IGG SUBCLASSES received FDA 510(k) clearance on 1991-06-12, under 510(k) number K911610.

Who is the listed applicant for ELISA COMBI-KIT HUMAN IGG SUBCLASSES?

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

What is the FDA product code for ELISA COMBI-KIT HUMAN IGG SUBCLASSES?

The FDA product code for ELISA COMBI-KIT HUMAN IGG SUBCLASSES is DEW.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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