FDA 510(k)

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX

K-Number: K001934 · 2000-07-24

Decision Date2000-07-24

Product CodeDFC

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX 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 2000-07-24 under 510(k) number K001934. 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) & LP(A) CALIBRATOR/BECKMAN CX?

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX is a medical device that received FDA 510(k) clearance on 2000-07-24. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K001934.

When did WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX receive FDA 510(k) clearance?

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX received FDA 510(k) clearance on 2000-07-24, under 510(k) number K001934.

Who is the listed applicant for WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX?

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) & LP(A) CALIBRATOR/BECKMAN CX?

The FDA product code for WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX is DFC.

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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 K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR K062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

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Related Devices (Code: DFC)

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics Operations K211058Lp(a) UltraSENTINEL CH. SpA K180074Diazyme 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.