FDA 510(k)

WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

K-Number: K001004 · 2000-06-01

Decision Date2000-06-01

Product CodeJIS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

WAKO APOLIPOPROTEIN HIGH LEVEL 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 2000-06-01 under 510(k) number K001004. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR?

WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR is a medical device that received FDA 510(k) clearance on 2000-06-01. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K001004.

When did WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR receive FDA 510(k) clearance?

WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR received FDA 510(k) clearance on 2000-06-01, under 510(k) number K001004.

Who is the listed applicant for WAKO APOLIPOPROTEIN HIGH LEVEL 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 APOLIPOPROTEIN HIGH LEVEL CALIBRATOR?

The FDA product code for WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR is JIS.

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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 K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

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Related Devices (Code: JIS)

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories Limited K061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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.