FDA 510(k)

WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR

K-Number: K061775 · 2007-02-23

Decision Date2007-02-23

Product CodeJFY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE 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 2007-02-23 under 510(k) number K061775. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR?

WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K061775.

When did WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR receive FDA 510(k) clearance?

WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR received FDA 510(k) clearance on 2007-02-23, under 510(k) number K061775.

Who is the listed applicant for WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE 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 CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR?

The FDA product code for WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR is JFY.

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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 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 K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

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Related Devices (Code: JFY)

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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.