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FDA 510(k)

TINA-QUANT [A] TRANSFERRIN

K-Number: K871896 · 1987-06-15

ApplicantBoehringer Mannheim Corp.
Decision Date1987-06-15
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT [A] TRANSFERRIN is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1987-06-15 under 510(k) number K871896. 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 TINA-QUANT [A] TRANSFERRIN?

TINA-QUANT [A] TRANSFERRIN is a medical device that received FDA 510(k) clearance on 1987-06-15. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K871896.

When did TINA-QUANT [A] TRANSFERRIN receive FDA 510(k) clearance?

TINA-QUANT [A] TRANSFERRIN received FDA 510(k) clearance on 1987-06-15, under 510(k) number K871896.

Who is the listed applicant for TINA-QUANT [A] TRANSFERRIN?

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

What is the FDA product code for TINA-QUANT [A] TRANSFERRIN?

The FDA product code for TINA-QUANT [A] TRANSFERRIN is DDG.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: DDG)

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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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