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FDA 510(k)

J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS

K-Number: K801434 · 1980-07-08

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-07-08
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801434. 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 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS?

J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801434.

When did J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS receive FDA 510(k) clearance?

J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801434.

Who is the listed applicant for J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS?

The FDA product code for J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS is DDG.

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Other records listing J.T. Baker Chemical Co. as applicant

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K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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