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FDA 510(k)

WAKO AUTOKIT LP(A)/DADE DEMENSION

K-Number: K001919 · 2000-07-23

ApplicantWako Chemicals USA, Inc.
Decision Date2000-07-23
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WAKO AUTOKIT LP(A)/DADE DEMENSION 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 2000-07-23 under 510(k) number K001919. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO AUTOKIT LP(A)/DADE DEMENSION?

WAKO AUTOKIT LP(A)/DADE DEMENSION is a medical device that received FDA 510(k) clearance on 2000-07-23. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K001919.

When did WAKO AUTOKIT LP(A)/DADE DEMENSION receive FDA 510(k) clearance?

WAKO AUTOKIT LP(A)/DADE DEMENSION received FDA 510(k) clearance on 2000-07-23, under 510(k) number K001919.

Who is the listed applicant for WAKO AUTOKIT LP(A)/DADE DEMENSION?

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 LP(A)/DADE DEMENSION?

The FDA product code for WAKO AUTOKIT LP(A)/DADE DEMENSION is DFC.

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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: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

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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