FDA 510(k)

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR

K-Number: K993162 · 1999-11-12

Decision Date1999-11-12

Product CodeDDG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Wako Chemicals USA, Inc.. It received FDA 510(k) clearance on 1999-11-12 under 510(k) number K993162. 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 WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR?

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1999-11-12. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K993162.

When did WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR receive FDA 510(k) clearance?

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR received FDA 510(k) clearance on 1999-11-12, under 510(k) number K993162.

Who is the listed applicant for WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR?

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

What is the FDA product code for WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR?

The FDA product code for WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR is DDG.

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Other records listing Wako Chemicals USA, Inc. as applicant

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION K080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR K062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

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Related Devices (Code: DDG)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.