Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wako Chemicals USA, Inc. · Predicate Candidate Screening
124 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
165 days90th percentile
124clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBR | Wako Chemicals USA, Inc. | 2011-02-23 | 370 | 1 |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 9 | Wako Chemicals USA, Inc. | 2008-07-18 | 183 | 0 |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991 | Wako Chemicals USA, Inc. | 2008-07-17 | 182 | 0 |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATO | Wako Chemicals USA, Inc. | 2007-02-23 | 245 | 0 |
| K062368 | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, | Wako Chemicals USA, Inc. | 2007-01-31 | 170 | 0 |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-228 | Wako Chemicals USA, Inc. | 2005-12-30 | 52 | 0 |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23 | Wako Chemicals USA, Inc. | 2005-12-30 | 52 | 0 |
| DEN050002 | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LI | Wako Chemicals USA, Inc. | 2005-05-19 | 42 | 0 |
| K042551 | MULTI-CHEM CALIBRATOR A | Wako Chemicals USA, Inc. | 2004-11-16 | 57 | 0 |
| K042549 | MULTI CHEM CAL B | Wako Chemicals USA, Inc. | 2004-11-08 | 49 | 0 |
| K042550 | MULTI-LIPID CALIBRATOR | Wako Chemicals USA, Inc. | 2004-11-08 | 49 | 0 |
| K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 | Wako Chemicals USA, Inc. | 2004-05-17 | 39 | 1 |
| K033860 | AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY | Wako Chemicals USA, Inc. | 2004-04-23 | 133 | 0 |
| K040226 | WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR | Wako Chemicals USA, Inc. | 2004-03-25 | 52 | 0 |
| K024280 | WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET | Wako Chemicals USA, Inc. | 2003-06-06 | 165 | 0 |
| K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SE | Wako Chemicals USA, Inc. | 2003-04-11 | 71 | 0 |
| K024281 | WAKO L-TYPE GLUCOSE 2 | Wako Chemicals USA, Inc. | 2003-02-24 | 63 | 0 |
| K030065 | WAKO NEFA LINEARITY SET | Wako Chemicals USA, Inc. | 2003-02-11 | 35 | 0 |
| K020972 | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | Wako Chemicals USA, Inc. | 2002-09-09 | 167 | 0 |
| K010332 | WAKO IMMUNOASSAY CALIBRATOR SET | Wako Chemicals USA, Inc. | 2001-08-01 | 180 | 0 |
| K010325 | WAKO AUTOKIT C4 | Wako Chemicals USA, Inc. | 2001-06-25 | 143 | 0 |
| K010326 | WAKO AUTOKIT C3 | Wako Chemicals USA, Inc. | 2001-06-25 | 143 | 0 |
| K010334 | WAKO LIPID CALIBRATOR | Wako Chemicals USA, Inc. | 2001-06-25 | 143 | 0 |
| K003342 | WAKO CRP-UL, CRP-UL CALIBRATOR SET | Wako Chemicals USA, Inc. | 2001-01-22 | 89 | 0 |
| K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | Wako Chemicals USA, Inc. | 2000-07-24 | 28 | 0 |
| K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | Wako Chemicals USA, Inc. | 2000-07-24 | 28 | 0 |
| K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | Wako Chemicals USA, Inc. | 2000-07-24 | 28 | 0 |
| K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | 2000-07-24 | 28 | 0 |
| K001919 | WAKO AUTOKIT LP(A)/DADE DEMENSION | Wako Chemicals USA, Inc. | 2000-07-23 | 30 | 0 |
| K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, | Wako Chemicals USA, Inc. | 2000-07-23 | 30 | 0 |
| K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 | Wako Chemicals USA, Inc. | 2000-07-23 | 30 | 0 |
| K001004 | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR | Wako Chemicals USA, Inc. | 2000-06-01 | 64 | 0 |
| K001005 | WAKO HDL-C/LDL-C CALIBRATOR | Wako Chemicals USA, Inc. | 2000-06-01 | 64 | 0 |
| K001002 | WAKO LIPASE CALIBRATOR | Wako Chemicals USA, Inc. | 2000-05-24 | 56 | 0 |
| K993925 | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | 2000-04-03 | 137 | 0 |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN | Wako Chemicals USA, Inc. | 2000-01-18 | 61 | 0 |
| K993924 | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN | Wako Chemicals USA, Inc. | 2000-01-14 | 57 | 0 |
| K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULI | Wako Chemicals USA, Inc. | 2000-01-14 | 57 | 0 |
| K993468 | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | 1999-12-16 | 64 | 0 |
| K993162 | WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR | Wako Chemicals USA, Inc. | 1999-11-12 | 51 | 0 |
| K993219 | WAKO BILIRUBIN CALIBRATOR | Wako Chemicals USA, Inc. | 1999-11-09 | 43 | 0 |
| K993466 | WAKO L-TYPE TRIGLYCERIDE TEST | Wako Chemicals USA, Inc. | 1999-11-09 | 27 | 0 |
| K993469 | WAKO L-TYPE UA F TEST | Wako Chemicals USA, Inc. | 1999-11-09 | 27 | 0 |
| K981446 | WAKO AUTOKIT LP(A) | Wako Chemicals USA, Inc. | 1999-03-09 | 321 | 2 |
| K984122 | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | Wako Chemicals USA, Inc. | 1999-01-20 | 63 | 0 |
| K984119 | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | Wako Chemicals USA, Inc. | 1999-01-15 | 58 | 0 |
| K984184 | WAKO L-TYPE AMYLASE | Wako Chemicals USA, Inc. | 1999-01-13 | 51 | 0 |
| K982271 | WAKO DIRECT LDL-C | Wako Chemicals USA, Inc. | 1998-09-22 | 85 | 0 |
| K973055 | WAKO CH50 LINEARITY SET | Wako Chemicals USA, Inc. | 1997-09-25 | 41 | 0 |
| K973072 | WAKO NEFA LINEARITY SET | Wako Chemicals USA, Inc. | 1997-09-12 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda