Wako Chemicals USA, Inc.
Wako Chemicals USA, Inc. holds FDA 510(k) medical device clearances, first cleared 1981, most recent 2011.
Top product codes for Wako Chemicals USA, Inc.
Recent clearances by Wako Chemicals USA, Inc.
1–100 of 124- K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
- K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
- K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
- K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
- K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
- K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
- K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
- DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
- K042551 — MULTI-CHEM CALIBRATOR A
- K042549 — MULTI CHEM CAL B
- K042550 — MULTI-LIPID CALIBRATOR
- K040918 — WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
- K033860 — AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
- K040226 — WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
- K024280 — WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
- K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
- K024281 — WAKO L-TYPE GLUCOSE 2
- K030065 — WAKO NEFA LINEARITY SET
- K020972 — WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
- K010332 — WAKO IMMUNOASSAY CALIBRATOR SET
- K010325 — WAKO AUTOKIT C4
- K010326 — WAKO AUTOKIT C3
- K010334 — WAKO LIPID CALIBRATOR
- K003342 — WAKO CRP-UL, CRP-UL CALIBRATOR SET
- K001929 — WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
- K001931 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
- K001933 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
- K001934 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
- K001919 — WAKO AUTOKIT LP(A)/DADE DEMENSION
- K001920 — WAKO AUTOKIT LP(A)/ RA,500/1000,
- K001921 — WAKO AUTOKIT LP(A)/EXPRESS 550
- K001004 — WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
- K001005 — WAKO HDL-C/LDL-C CALIBRATOR
- K001002 — WAKO LIPASE CALIBRATOR
- K993925 — WAKO L-TYPE UN TEST
- K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993924 — WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
- K993468 — WAKO L-TYPE GOT TEST
- K993162 — WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
- K993219 — WAKO BILIRUBIN CALIBRATOR
- K993466 — WAKO L-TYPE TRIGLYCERIDE TEST
- K993469 — WAKO L-TYPE UA F TEST
- K981446 — WAKO AUTOKIT LP(A)
- K984122 — WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
- K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
- K984184 — WAKO L-TYPE AMYLASE
- K982271 — WAKO DIRECT LDL-C
- K973055 — WAKO CH50 LINEARITY SET
- K973072 — WAKO NEFA LINEARITY SET
- K970986 — WAKO DIRECT BILIRUBIN V
- K970985 — WAKO TOTAL BILIRUBIN V
- K963847 — WAKO DIRECT HDL-C
- K960874 — COMPLEMENT CONTROL
- K955156 — WAKO AUTOKIT CRP NEW
- K954657 — WAKO AUTOKIT APO B
- K954145 — WAKO AUTOKIT CH50
- K950172 — WAKO AUTOKIT GLUCOSE
- K952615 — WAKO AUTOKIT APO A1
- K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
- K923070 — WAKO IGG-HA
- K922151 — WAKO AUTOKIT RF
- K921249 — WAKO AUTOKIT LIPASE-COLOR
- K920531 — WAKO AUTOKIT MICRO TP
- K912024 — AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
- K902216 — WAKO(TM) MICRO-ALBUMIN
- K901544 — WAKO(TM) AUTOKIT URIC ACID
- K895984 — WAKO(TM) AUTOKIT GAMMA-GT
- K895598 — WAKO(TM) AUTOKIT CRP
- K883059 — WAKO(TM) AUTOKIT AMYLASE
- K882374 — WAKO(TM) CRP
- K880784 — WAKO(TM) IGG-HA DIRECT
- K880803 — WAKO(TM) IGA-HA DIRECT
- K880828 — WAKO(TM) IGM-HA DIRECT
- K880312 — WAKO(TM) AUTOKIT TOTAL PROTEIN
- K880313 — WAKO(TM) AUTOKIT ALBUMIN
- K880731 — WAKO AUTOKIT URIC ACID
- K880311 — WAKO(TM) AUTOKIT CHOLESTEROL
- K873409 — WAKO(TM) PRETEST 6A
- K875176 — WAKO(TM) UIBC
- K873366 — WAKO(TM) PRETEST 5A
- K874640 — WAKO(TM) AUTOKIT LIPASE
- K871755 — PROTEIN STANDARD CALIBRATOR
- K874263 — WAKO(TM) FE C
- K873201 — WAKO(TM) AUTOKIT CK-NAC
- K873333 — WAKO(TM) AUTOKIT ALP
- K873334 — WAKO(TM) AUTOKIT CALCIUM
- K873335 — WAKO(TM) AUTOKIT UREA N
- K871759 — G-GT STANDARD CALIBRATOR
- K873553 — WAKO(TM) PRETEST 8A
- K872051 — CALCIUM CALIBRATOR
- K863920 — WAKO(TM) ZN TEST
- K872918 — GIT SERUM-FREE MEDIUM FOR CELL CULTURE
- K872263 — TOTAL BILIRUBIN STANDARD CALIBRATOR
- K870095 — BILIRUBIN TESTER
- K871756 — CREATININE STANDARD SOLUTION CALIBRATOR
- K871758 — GLUCOSE STANDARD SOLUTION CALIBRATOR
- K871762 — MAGNESIUM STANDARD SOLUTION CALIBRATOR
- K871763 — NEFA STANDARD SOLUTION CALIBRATOR
- K871764 — INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.