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

FDA 510(k) Regulatory Record - Wako Chemicals USA, Inc. Chemistry ✕

89 devices

1-12 of 89

Cleared Jul 18, 2008

APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601,...

Chemistry · 183d

Cleared Jul 17, 2008

APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201

Chemistry · 182d

Cleared Feb 23, 2007

WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR

Chemistry · 245d

Cleared Dec 30, 2005

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

Chemistry · 52d

Cleared Dec 30, 2005

WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

Chemistry · 52d

Cleared Nov 16, 2004

MULTI-CHEM CALIBRATOR A

Chemistry · 57d

Cleared Nov 08, 2004

MULTI CHEM CAL B

Chemistry · 49d

Cleared Nov 08, 2004

MULTI-LIPID CALIBRATOR

Chemistry · 49d

Cleared May 17, 2004

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

Chemistry · 39d

Cleared Apr 23, 2004

AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR

Chemistry · 133d

Cleared Mar 25, 2004

WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN...

Chemistry · 52d

Cleared Jun 06, 2003

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET

Chemistry · 165d

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