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FDA 510(k)

N ANTISERUM TO HUMAN TRANSFERRIN

K-Number: K972840 · 1997-10-17

ApplicantBehring Diagnostics, Inc.
Decision Date1997-10-17
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N ANTISERUM TO HUMAN TRANSFERRIN is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-10-17 under 510(k) number K972840. 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 N ANTISERUM TO HUMAN TRANSFERRIN?

N ANTISERUM TO HUMAN TRANSFERRIN is a medical device that received FDA 510(k) clearance on 1997-10-17. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K972840.

When did N ANTISERUM TO HUMAN TRANSFERRIN receive FDA 510(k) clearance?

N ANTISERUM TO HUMAN TRANSFERRIN received FDA 510(k) clearance on 1997-10-17, under 510(k) number K972840.

Who is the listed applicant for N ANTISERUM TO HUMAN TRANSFERRIN?

The FDA 510(k) record lists Behring Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N ANTISERUM TO HUMAN TRANSFERRIN?

The FDA product code for N ANTISERUM TO HUMAN TRANSFERRIN is DDG.

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Other records listing Behring Diagnostics, 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENTK972011OPUS ETHANOL

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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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