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FDA 510(k)

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM

K-Number: K851284 · 1985-06-11

ApplicantCooper Biomedical, Inc.
Decision Date1985-06-11
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1985-06-11 under 510(k) number K851284. 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 RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM?

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM is a medical device that received FDA 510(k) clearance on 1985-06-11. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K851284.

When did RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM receive FDA 510(k) clearance?

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM received FDA 510(k) clearance on 1985-06-11, under 510(k) number K851284.

Who is the listed applicant for RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM?

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

What is the FDA product code for RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM?

The FDA product code for RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM is CZP.

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Other records listing Cooper Biomedical, 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.

K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTK864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOK863301DEMAND TOTAL PROTEINK861926WORTHINGTON HDL PRECIPITATING REAGENT SETK854130DEMAND ETHYL ALCOHOLK853949DEMAND ACID PHOSPHATASE REAGENT

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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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