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FDA 510(k)

WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR

K-Number: K984119 · 1999-01-15

ApplicantWako Chemicals USA, Inc.
Decision Date1999-01-15
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO L-TYPE FE, WAKO L-TYPE 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 1999-01-15 under 510(k) number K984119. The device is classified under product code CFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR?

WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1999-01-15. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K984119.

When did WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR receive FDA 510(k) clearance?

WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR received FDA 510(k) clearance on 1999-01-15, under 510(k) number K984119.

Who is the listed applicant for WAKO L-TYPE FE, WAKO L-TYPE 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 L-TYPE FE, WAKO L-TYPE CALIBRATOR?

The FDA product code for WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR is CFM.

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Other records listing Wako Chemicals USA, 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.

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONK080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORK062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

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Related Devices (Code: CFM)

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.

K981581IRONAbbott LaboratoriesK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERCatachem, Inc.K913705ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.K902918SYNERMED SERUM IRON REAGENT KITSynermed, Inc.K895047CLINISTAT POTASSIUM REAGENT TESTHeraeus Kulzer, 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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