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Wako Chemicals USA, Inc.

124 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION (K100464)Wako Chemicals USA, Inc.2011-02-23
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125)Wako Chemicals USA, Inc.2008-07-18
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (K080123)Wako Chemicals USA, Inc.2008-07-17
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (K061775)Wako Chemicals USA, Inc.2007-02-23
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 (K062368)Wako Chemicals USA, Inc.2007-01-31
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (K053132)Wako Chemicals USA, Inc.2005-12-30
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (K053131)Wako Chemicals USA, Inc.2005-12-30
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (DEN050002)Wako Chemicals USA, Inc.2005-05-19
MULTI-CHEM CALIBRATOR A (K042551)Wako Chemicals USA, Inc.2004-11-16
MULTI-LIPID CALIBRATOR (K042550)Wako Chemicals USA, Inc.2004-11-08
MULTI CHEM CAL B (K042549)Wako Chemicals USA, Inc.2004-11-08
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 (K040918)Wako Chemicals USA, Inc.2004-05-17
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR (K033860)Wako Chemicals USA, Inc.2004-04-23
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET (K040226)Wako Chemicals USA, Inc.2004-03-25
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET (K024280)Wako Chemicals USA, Inc.2003-06-06
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET (K030320)Wako Chemicals USA, Inc.2003-04-11
WAKO L-TYPE GLUCOSE 2 (K024281)Wako Chemicals USA, Inc.2003-02-24
WAKO NEFA LINEARITY SET (K030065)Wako Chemicals USA, Inc.2003-02-11
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET (K020972)Wako Chemicals USA, Inc.2002-09-09
WAKO IMMUNOASSAY CALIBRATOR SET (K010332)Wako Chemicals USA, Inc.2001-08-01
WAKO LIPID CALIBRATOR (K010334)Wako Chemicals USA, Inc.2001-06-25
WAKO AUTOKIT C3 (K010326)Wako Chemicals USA, Inc.2001-06-25
WAKO AUTOKIT C4 (K010325)Wako Chemicals USA, Inc.2001-06-25
WAKO CRP-UL, CRP-UL CALIBRATOR SET (K003342)Wako Chemicals USA, Inc.2001-01-22
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET (K001931)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA (K001929)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO (K001933)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX (K001934)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A)/DADE DEMENSION (K001919)Wako Chemicals USA, Inc.2000-07-23
WAKO AUTOKIT LP(A)/ RA,500/1000, (K001920)Wako Chemicals USA, Inc.2000-07-23
WAKO AUTOKIT LP(A)/EXPRESS 550 (K001921)Wako Chemicals USA, Inc.2000-07-23
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR (K001004)Wako Chemicals USA, Inc.2000-06-01
WAKO HDL-C/LDL-C CALIBRATOR (K001005)Wako Chemicals USA, Inc.2000-06-01
WAKO LIPASE CALIBRATOR (K001002)Wako Chemicals USA, Inc.2000-05-24
WAKO L-TYPE UN TEST (K993925)Wako Chemicals USA, Inc.2000-04-03
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993928)Wako Chemicals USA, Inc.2000-01-18
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (K993927)Wako Chemicals USA, Inc.2000-01-14
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993924)Wako Chemicals USA, Inc.2000-01-14
WAKO L-TYPE GOT TEST (K993468)Wako Chemicals USA, Inc.1999-12-16
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR (K993162)Wako Chemicals USA, Inc.1999-11-12
WAKO BILIRUBIN CALIBRATOR (K993219)Wako Chemicals USA, Inc.1999-11-09
WAKO L-TYPE TRIGLYCERIDE TEST (K993466)Wako Chemicals USA, Inc.1999-11-09
WAKO L-TYPE UA F TEST (K993469)Wako Chemicals USA, Inc.1999-11-09
WAKO AUTOKIT LP(A) (K981446)Wako Chemicals USA, Inc.1999-03-09
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR (K984122)Wako Chemicals USA, Inc.1999-01-20
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (K984119)Wako Chemicals USA, Inc.1999-01-15
WAKO L-TYPE AMYLASE (K984184)Wako Chemicals USA, Inc.1999-01-13
WAKO DIRECT LDL-C (K982271)Wako Chemicals USA, Inc.1998-09-22
WAKO CH50 LINEARITY SET (K973055)Wako Chemicals USA, Inc.1997-09-25
WAKO NEFA LINEARITY SET (K973072)Wako Chemicals USA, Inc.1997-09-12
WAKO DIRECT BILIRUBIN V (K970986)Wako Chemicals USA, Inc.1997-05-07
WAKO TOTAL BILIRUBIN V (K970985)Wako Chemicals USA, Inc.1997-04-21
WAKO DIRECT HDL-C (K963847)Wako Chemicals USA, Inc.1996-12-24
COMPLEMENT CONTROL (K960874)Wako Chemicals USA, Inc.1996-06-14
WAKO AUTOKIT CRP NEW (K955156)Wako Chemicals USA, Inc.1996-02-16
WAKO AUTOKIT APO B (K954657)Wako Chemicals USA, Inc.1995-12-20
WAKO AUTOKIT CH50 (K954145)Wako Chemicals USA, Inc.1995-12-18
WAKO AUTOKIT GLUCOSE (K950172)Wako Chemicals USA, Inc.1995-10-05
WAKO AUTOKIT APO A1 (K952615)Wako Chemicals USA, Inc.1995-09-08
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (K944664)Wako Chemicals USA, Inc.1995-02-07
WAKO IGG-HA (K923070)Wako Chemicals USA, Inc.1992-08-20
WAKO AUTOKIT RF (K922151)Wako Chemicals USA, Inc.1992-07-28
WAKO AUTOKIT LIPASE-COLOR (K921249)Wako Chemicals USA, Inc.1992-07-21
WAKO AUTOKIT MICRO TP (K920531)Wako Chemicals USA, Inc.1992-07-14
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) (K912024)Wako Chemicals USA, Inc.1991-07-19
WAKO(TM) MICRO-ALBUMIN (K902216)Wako Chemicals USA, Inc.1990-06-18
WAKO(TM) AUTOKIT URIC ACID (K901544)Wako Chemicals USA, Inc.1990-05-14
WAKO(TM) AUTOKIT GAMMA-GT (K895984)Wako Chemicals USA, Inc.1989-11-08
WAKO(TM) AUTOKIT CRP (K895598)Wako Chemicals USA, Inc.1989-09-27
WAKO(TM) AUTOKIT AMYLASE (K883059)Wako Chemicals USA, Inc.1988-08-30
WAKO(TM) CRP (K882374)Wako Chemicals USA, Inc.1988-07-08
WAKO(TM) IGG-HA DIRECT (K880784)Wako Chemicals USA, Inc.1988-06-06
WAKO(TM) IGA-HA DIRECT (K880803)Wako Chemicals USA, Inc.1988-03-29
WAKO(TM) IGM-HA DIRECT (K880828)Wako Chemicals USA, Inc.1988-03-25
WAKO(TM) AUTOKIT TOTAL PROTEIN (K880312)Wako Chemicals USA, Inc.1988-03-24
WAKO(TM) AUTOKIT ALBUMIN (K880313)Wako Chemicals USA, Inc.1988-03-24
WAKO AUTOKIT URIC ACID (K880731)Wako Chemicals USA, Inc.1988-03-24
WAKO(TM) AUTOKIT CHOLESTEROL (K880311)Wako Chemicals USA, Inc.1988-03-01
WAKO(TM) PRETEST 6A (K873409)Wako Chemicals USA, Inc.1988-02-11
WAKO(TM) UIBC (K875176)Wako Chemicals USA, Inc.1988-02-02
WAKO(TM) PRETEST 5A (K873366)Wako Chemicals USA, Inc.1988-01-21
WAKO(TM) AUTOKIT LIPASE (K874640)Wako Chemicals USA, Inc.1987-12-22
PROTEIN STANDARD CALIBRATOR (K871755)Wako Chemicals USA, Inc.1987-11-23
WAKO(TM) FE C (K874263)Wako Chemicals USA, Inc.1987-11-23
WAKO(TM) AUTOKIT CK-NAC (K873201)Wako Chemicals USA, Inc.1987-11-05
WAKO(TM) AUTOKIT UREA N (K873335)Wako Chemicals USA, Inc.1987-10-02
WAKO(TM) AUTOKIT ALP (K873333)Wako Chemicals USA, Inc.1987-10-02
WAKO(TM) AUTOKIT CALCIUM (K873334)Wako Chemicals USA, Inc.1987-10-02
G-GT STANDARD CALIBRATOR (K871759)Wako Chemicals USA, Inc.1987-09-29
WAKO(TM) PRETEST 8A (K873553)Wako Chemicals USA, Inc.1987-09-22
CALCIUM CALIBRATOR (K872051)Wako Chemicals USA, Inc.1987-09-18
WAKO(TM) ZN TEST (K863920)Wako Chemicals USA, Inc.1987-09-16
GIT SERUM-FREE MEDIUM FOR CELL CULTURE (K872918)Wako Chemicals USA, Inc.1987-08-11
TOTAL BILIRUBIN STANDARD CALIBRATOR (K872263)Wako Chemicals USA, Inc.1987-07-22
BILIRUBIN TESTER (K870095)Wako Chemicals USA, Inc.1987-06-03
CREATININE STANDARD SOLUTION CALIBRATOR (K871756)Wako Chemicals USA, Inc.1987-05-27
NEFA STANDARD SOLUTION CALIBRATOR (K871763)Wako Chemicals USA, Inc.1987-05-26
UREA N STANDARD SOLUTION CALIBRATOR (K871767)Wako Chemicals USA, Inc.1987-05-26
MAGNESIUM STANDARD SOLUTION CALIBRATOR (K871762)Wako Chemicals USA, Inc.1987-05-26
URIC ACID STANDARD SOLUTION CALIBRATOR (K871768)Wako Chemicals USA, Inc.1987-05-26
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