Wako Chemicals USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
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.
FDA 510(k) Regulatory Record - Wako Chemicals USA, Inc.
124 devices
Cleared
Feb 23, 2011
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL...
Immunology
370d
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
Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
Immunology
170d
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
Not Cleared
May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
Immunology
42d
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
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