Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION, APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201, APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
124
Total
123
Cleared
1
Denied
FDA 510(k) Regulatory Record - Wako Chemicals USA, Inc. Chemistry ✕
89 devices
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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