Medical Device Manufacturer · US , Mchenry , IL

Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices

124 submissions · 123 cleared · Since 1981
124
Total
123
Cleared
1
Denied

Wako Chemicals USA, Inc. has 123 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.

Historical record: 123 cleared submissions from 1981 to 2011.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

124 devices
1–12 of 124
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
K100464 · NSF Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment · Immunology
Feb 2011 370d
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · Chemistry
Jul 2008 183d
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · CFR Hexokinase, Glucose · Chemistry
Jul 2008 182d
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · JFY Enzymatic Method, Creatinine · Chemistry
Feb 2007 245d
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
K062368 · OAU Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma · Immunology
Jan 2007 170d
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · JFM Enzymatic Method, Bilirubin · Chemistry
Dec 2005 52d
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · JFM Enzymatic Method, Bilirubin · Chemistry
Dec 2005 52d
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
DEN050002 · NSF Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment · Immunology
May 2005 42d
MULTI-CHEM CALIBRATOR A
K042551 · JIX Calibrator, Multi-analyte Mixture · Chemistry
Nov 2004 57d
MULTI CHEM CAL B
K042549 · JIX Calibrator, Multi-analyte Mixture · Chemistry
Nov 2004 49d
MULTI-LIPID CALIBRATOR
K042550 · JIX Calibrator, Multi-analyte Mixture · Chemistry
Nov 2004 49d
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
K040918 · JJX Single (specified) Analyte Controls (assayed And Unassayed) · Chemistry
May 2004 39d

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