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FDA 510(k)

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT

K-Number: K060130 · 2006-02-13

ApplicantBeckman Coulter, Inc.
Decision Date2006-02-13
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2006-02-13 under 510(k) number K060130. 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 IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT?

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT is a medical device that received FDA 510(k) clearance on 2006-02-13. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K060130.

When did IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT receive FDA 510(k) clearance?

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT received FDA 510(k) clearance on 2006-02-13, under 510(k) number K060130.

Who is the listed applicant for IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT?

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

What is the FDA product code for IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT?

The FDA product code for IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT is CZP.

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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 SASK040435ROCHE 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 LaboratoriesK962200QUANTEX IGAInstrumentation Laboratory CO

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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