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FDA 510(k)

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

K-Number: K040918 · 2004-05-17

ApplicantWako Chemicals USA, Inc.
Decision Date2004-05-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 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 2004-05-17 under 510(k) number K040918. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2?

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K040918.

When did WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 receive FDA 510(k) clearance?

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 received FDA 510(k) clearance on 2004-05-17, under 510(k) number K040918.

Who is the listed applicant for WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2?

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 LIPID CONTROL, LEVEL 1 AND LEVEL 2?

The FDA product code for WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 is JJX.

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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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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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