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FDA 510(k)

RANDOX TRANSFERRIN

K-Number: K002585 · 2001-02-05

ApplicantRandox Laboratories, Ltd.
Decision Date2001-02-05
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RANDOX TRANSFERRIN is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2001-02-05 under 510(k) number K002585. 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 RANDOX TRANSFERRIN?

RANDOX TRANSFERRIN is a medical device that received FDA 510(k) clearance on 2001-02-05. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K002585.

When did RANDOX TRANSFERRIN receive FDA 510(k) clearance?

RANDOX TRANSFERRIN received FDA 510(k) clearance on 2001-02-05, under 510(k) number K002585.

Who is the listed applicant for RANDOX TRANSFERRIN?

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

What is the FDA product code for RANDOX TRANSFERRIN?

The FDA product code for RANDOX TRANSFERRIN is DDG.

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Other records listing Randox Laboratories, Ltd. as applicant

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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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