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FDA 510(k)

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN

K-Number: K851287 · 1985-05-24

ApplicantCooper Biomedical, Inc.
Decision Date1985-05-24
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN 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 1985-05-24 under 510(k) number K851287. The device is classified under product code DDG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN?

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN is a medical device that received FDA 510(k) clearance on 1985-05-24. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K851287.

When did RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN receive FDA 510(k) clearance?

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN received FDA 510(k) clearance on 1985-05-24, under 510(k) number K851287.

Who is the listed applicant for RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN?

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 IMMUNODIFFUSION PLATES TRANSFERRIN?

The FDA product code for RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN is DDG.

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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: DDG)

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.

K240987Access sTfRBeckman Coulter, Inc.K190495TransferrinBiosystems S.A.K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo)K120236TRANSFERRIN KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K080634ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495Beckman Coulter, Inc.K081299DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTASiemens Healthcare Diagnostics, Inc.

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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