Wako Chemicals USA, Inc.

FDA 510(k) & PMA Approved Devices — 123 products

Total Devices123

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K100464	UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION	NSF	2011-02-23	View
510(k)	K080125	APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201	LBS	2008-07-18	View
510(k)	K080123	APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201	CFR	2008-07-17	View
510(k)	K061775	WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR	JFY	2007-02-23	View
510(k)	K062368	WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401	OAU	2007-01-31	View
510(k)	K053131	WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191	JFM	2005-12-30	View
510(k)	K053132	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791	JFM	2005-12-30	View
510(k)	K042551	MULTI-CHEM CALIBRATOR A	JIX	2004-11-16	View
510(k)	K042549	MULTI CHEM CAL B	JIX	2004-11-08	View
510(k)	K042550	MULTI-LIPID CALIBRATOR	JIX	2004-11-08	View
510(k)	K040918	WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2	JJX	2004-05-17	View
510(k)	K033860	AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR	JIT	2004-04-23	View
510(k)	K040226	WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET	JIT	2004-03-25	View
510(k)	K024280	WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET	DCK	2003-06-06	View
510(k)	K030320	WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET	JIS	2003-04-11	View
510(k)	K024281	WAKO L-TYPE GLUCOSE 2	CFR	2003-02-24	View
510(k)	K030065	WAKO NEFA LINEARITY SET	JJX	2003-02-11	View
510(k)	K020972	WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET	DHR	2002-09-09	View
510(k)	K010332	WAKO IMMUNOASSAY CALIBRATOR SET	JIT	2001-08-01	View
510(k)	K010334	WAKO LIPID CALIBRATOR	JIT	2001-06-25	View