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FDA 510(k)

WAKO AUTOKIT C4

K-Number: K010325 · 2001-06-25

ApplicantWako Chemicals USA, Inc.
Decision Date2001-06-25
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WAKO AUTOKIT C4 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 2001-06-25 under 510(k) number K010325. The device is classified under product code DBI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO AUTOKIT C4?

WAKO AUTOKIT C4 is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K010325.

When did WAKO AUTOKIT C4 receive FDA 510(k) clearance?

WAKO AUTOKIT C4 received FDA 510(k) clearance on 2001-06-25, under 510(k) number K010325.

Who is the listed applicant for WAKO AUTOKIT C4?

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 AUTOKIT C4?

The FDA product code for WAKO AUTOKIT C4 is DBI.

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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: DBI)

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.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.K993481K-ASSAY C4Kamiya Biomedical Co.

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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