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FDA 510(k)

GILFORD IMMUNOGLOBULIN A REAGENT

K-Number: K853467 · 1985-09-16

ApplicantGilford
Decision Date1985-09-16
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GILFORD IMMUNOGLOBULIN A REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K853467. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILFORD IMMUNOGLOBULIN A REAGENT?

GILFORD IMMUNOGLOBULIN A REAGENT is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Gilford. The 510(k) number is K853467.

When did GILFORD IMMUNOGLOBULIN A REAGENT receive FDA 510(k) clearance?

GILFORD IMMUNOGLOBULIN A REAGENT received FDA 510(k) clearance on 1985-09-16, under 510(k) number K853467.

Who is the listed applicant for GILFORD IMMUNOGLOBULIN A REAGENT?

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

What is the FDA product code for GILFORD IMMUNOGLOBULIN A REAGENT?

The FDA product code for GILFORD IMMUNOGLOBULIN A REAGENT is CZP.

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Other records listing Gilford 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.

K853469GILFORD IMMUNOGLOBULIN M REAGENTK853465GILFORD IMMUNOGLOBULIN G REAGENTK853466GILFORD C3 COMPLEMENT REAGENTK853468GILFORD C4 COMPLEMENT REAGENTK851202GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROLK842500DATA MGMT. SYSTEM

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott 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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