Company ยท US
Wako Chemicals USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2011. Name variants (Inc, Corp, punctuation) are merged.
124510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 16 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 10 |
| JIS | Calibrator, Primary | 7 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 4 |
| CEK | Biuret (Colorimetric), Total Protein | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 |
| JFM | Enzymatic Method, Bilirubin | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 2 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 |
| CFR | Hexokinase, Glucose | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2011 | K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION Wako Chemicals USA, Inc. | NSF |
| Jul 18, 2008 | K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 Wako Chemicals USA, Inc. | LBS |
| Jul 17, 2008 | K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 Wako Chemicals USA, Inc. | CFR |
| Feb 23, 2007 | K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR Wako Chemicals USA, Inc. | JFY |
| Jan 31, 2007 | K062368 | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 Wako Chemicals USA, Inc. | OAU |
| Dec 30, 2005 | K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 Wako Chemicals USA, Inc. | JFM |
| Dec 30, 2005 | K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 Wako Chemicals USA, Inc. | JFM |
| May 19, 2005 | DEN050002 | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS Wako Chemicals USA, Inc. | NSF |
| Nov 16, 2004 | K042551 | MULTI-CHEM CALIBRATOR A Wako Chemicals USA, Inc. | JIX |
| Nov 8, 2004 | K042550 | MULTI-LIPID CALIBRATOR Wako Chemicals USA, Inc. | JIX |
| Nov 8, 2004 | K042549 | MULTI CHEM CAL B Wako Chemicals USA, Inc. | JIX |
| May 17, 2004 | K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 Wako Chemicals USA, Inc. | JJX |
| Apr 23, 2004 | K033860 | AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR Wako Chemicals USA, Inc. | JIT |
| Mar 25, 2004 | K040226 | WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET Wako Chemicals USA, Inc. | JIT |
| Jun 6, 2003 | K024280 | WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET Wako Chemicals USA, Inc. | DCK |
| Apr 11, 2003 | K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET Wako Chemicals USA, Inc. | JIS |
| Feb 24, 2003 | K024281 | WAKO L-TYPE GLUCOSE 2 Wako Chemicals USA, Inc. | CFR |
| Feb 11, 2003 | K030065 | WAKO NEFA LINEARITY SET Wako Chemicals USA, Inc. | JJX |
| Sep 9, 2002 | K020972 | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET Wako Chemicals USA, Inc. | DHR |
| Aug 1, 2001 | K010332 | WAKO IMMUNOASSAY CALIBRATOR SET Wako Chemicals USA, Inc. | JIT |
| Jun 25, 2001 | K010334 | WAKO LIPID CALIBRATOR Wako Chemicals USA, Inc. | JIT |
| Jun 25, 2001 | K010326 | WAKO AUTOKIT C3 Wako Chemicals USA, Inc. | CZW |
| Jun 25, 2001 | K010325 | WAKO AUTOKIT C4 Wako Chemicals USA, Inc. | DBI |
| Jan 22, 2001 | K003342 | WAKO CRP-UL, CRP-UL CALIBRATOR SET Wako Chemicals USA, Inc. | DCN |
| Jul 24, 2000 | K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX Wako Chemicals USA, Inc. | DFC |
| Jul 24, 2000 | K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO Wako Chemicals USA, Inc. | DFC |
| Jul 24, 2000 | K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET Wako Chemicals USA, Inc. | DFC |
| Jul 24, 2000 | K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA Wako Chemicals USA, Inc. | DFC |
| Jul 23, 2000 | K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 Wako Chemicals USA, Inc. | DFC |
| Jul 23, 2000 | K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, Wako Chemicals USA, Inc. | DFC |
| Jul 23, 2000 | K001919 | WAKO AUTOKIT LP(A)/DADE DEMENSION Wako Chemicals USA, Inc. | DFC |
| Jun 1, 2000 | K001005 | WAKO HDL-C/LDL-C CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| Jun 1, 2000 | K001004 | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| May 24, 2000 | K001002 | WAKO LIPASE CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| Apr 3, 2000 | K993925 | WAKO L-TYPE UN TEST Wako Chemicals USA, Inc. | CDQ |
| Jan 18, 2000 | K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD Wako Chemicals USA, Inc. | DEW |
| Jan 14, 2000 | K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD Wako Chemicals USA, Inc. | CZP |
| Jan 14, 2000 | K993924 | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD Wako Chemicals USA, Inc. | CFN |
| Dec 16, 1999 | K993468 | WAKO L-TYPE GOT TEST Wako Chemicals USA, Inc. | CIT |
| Nov 12, 1999 | K993162 | WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR Wako Chemicals USA, Inc. | DDG |
| Nov 9, 1999 | K993469 | WAKO L-TYPE UA F TEST Wako Chemicals USA, Inc. | KNK |
| Nov 9, 1999 | K993466 | WAKO L-TYPE TRIGLYCERIDE TEST Wako Chemicals USA, Inc. | CDT |
| Nov 9, 1999 | K993219 | WAKO BILIRUBIN CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| Mar 9, 1999 | K981446 | WAKO AUTOKIT LP(A) Wako Chemicals USA, Inc. | DFC |
| Jan 20, 1999 | K984122 | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR Wako Chemicals USA, Inc. | JQF |
| Jan 15, 1999 | K984119 | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR Wako Chemicals USA, Inc. | CFM |
| Jan 13, 1999 | K984184 | WAKO L-TYPE AMYLASE Wako Chemicals USA, Inc. | JFJ |
| Sep 22, 1998 | K982271 | WAKO DIRECT LDL-C Wako Chemicals USA, Inc. | MRR |
| Sep 25, 1997 | K973055 | WAKO CH50 LINEARITY SET Wako Chemicals USA, Inc. | JIW |
| Sep 12, 1997 | K973072 | WAKO NEFA LINEARITY SET Wako Chemicals USA, Inc. | JJX |
Newest 50 of 124.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2012 | Wako Chemicals USA, Inc. Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo Terminated |
DFC | K981446 |
| Jul 12, 2007 | Wako Chemicals USA, Inc. NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bel Terminated |
JIT | None listed |
| Aug 25, 2006 | Wako Chemicals, USA Inc Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industrie Terminated |
MMY | K981446 |