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FDA 510(k)

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET

K-Number: K024280 · 2003-06-06

ApplicantWako Chemicals USA, Inc.
Decision Date2003-06-06
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET 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 2003-06-06 under 510(k) number K024280. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET?

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K024280.

When did WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET receive FDA 510(k) clearance?

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET received FDA 510(k) clearance on 2003-06-06, under 510(k) number K024280.

Who is the listed applicant for WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET?

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 CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET?

The FDA product code for WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET is DCK.

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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: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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.

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