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FDA 510(k)

WAKO IMMUNOASSAY CALIBRATOR SET

K-Number: K010332 · 2001-08-01

ApplicantWako Chemicals USA, Inc.
Decision Date2001-08-01
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO IMMUNOASSAY 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 2001-08-01 under 510(k) number K010332. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO IMMUNOASSAY CALIBRATOR SET?

WAKO IMMUNOASSAY CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2001-08-01. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K010332.

When did WAKO IMMUNOASSAY CALIBRATOR SET receive FDA 510(k) clearance?

WAKO IMMUNOASSAY CALIBRATOR SET received FDA 510(k) clearance on 2001-08-01, under 510(k) number K010332.

Who is the listed applicant for WAKO IMMUNOASSAY 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 IMMUNOASSAY CALIBRATOR SET?

The FDA product code for WAKO IMMUNOASSAY CALIBRATOR SET is JIT.

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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

View all 123 devices →

Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio 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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