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FDA 510(k)

TDX TRANSFERRIN DIAGNOSTIC KIT

K-Number: K854416 · 1986-02-21

ApplicantAbbott Laboratories
Decision Date1986-02-21
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TDX TRANSFERRIN DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-02-21 under 510(k) number K854416. 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 TDX TRANSFERRIN DIAGNOSTIC KIT?

TDX TRANSFERRIN DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1986-02-21. The listed applicant is Abbott Laboratories. The 510(k) number is K854416.

When did TDX TRANSFERRIN DIAGNOSTIC KIT receive FDA 510(k) clearance?

TDX TRANSFERRIN DIAGNOSTIC KIT received FDA 510(k) clearance on 1986-02-21, under 510(k) number K854416.

Who is the listed applicant for TDX TRANSFERRIN DIAGNOSTIC KIT?

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 TDX TRANSFERRIN DIAGNOSTIC KIT?

The FDA product code for TDX TRANSFERRIN DIAGNOSTIC KIT is DDG.

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Other records listing Abbott Laboratories 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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