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FDA 510(k)

TRF

K-Number: K983167 · 1998-11-04

ApplicantAbbott Laboratories
Decision Date1998-11-04
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TRF is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K983167. 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 TRF?

TRF is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Abbott Laboratories. The 510(k) number is K983167.

When did TRF receive FDA 510(k) clearance?

TRF received FDA 510(k) clearance on 1998-11-04, under 510(k) number K983167.

Who is the listed applicant for TRF?

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

What is the FDA product code for TRF?

The FDA product code for TRF is DDG.

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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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