Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIS — Predicate Candidate Screening
130 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
97 days90th percentile
130clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | Randox Laboratories Limited | 2012-08-14 | 27 | 0 |
| K061251 | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | Dade Behring, Inc. | 2006-05-31 | 27 | 0 |
| K060266 | DIMENSION IRON CALIBRATOR | Dade Behring, Inc. | 2006-03-09 | 36 | 1 |
| K053104 | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CA | Dade Behring, Inc. | 2005-12-23 | 49 | 0 |
| K032697 | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | Dade Behring, Inc. | 2003-11-07 | 66 | 0 |
| K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003-10-21 | 57 | 0 |
| K032296 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AN | Ortho-Clinical Diagnostics, Inc. | 2003-08-13 | 19 | 0 |
| K030964 | CALIBRATION PLASMA LMW HEPARIN | Instrumentation Laboratory CO | 2003-06-06 | 71 | 0 |
| K030546 | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | 2003-06-02 | 102 | 0 |
| K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SE | Wako Chemicals USA, Inc. | 2003-04-11 | 71 | 0 |
| K022682 | RANDOX C-REACTIVE PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2002-11-05 | 85 | 0 |
| K022901 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK A | Ortho-Clinical Diagnostics | 2002-09-27 | 24 | 0 |
| K013126 | N LP(A) STANDARD SY | Dade Behring, Inc. | 2001-11-09 | 51 | 0 |
| K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | 2001-10-16 | 49 | 0 |
| K011568 | RANDOX LIPOPROTEIN | Randox Laboratories, Ltd. | 2001-09-28 | 130 | 2 |
| K010696 | BECKMAN COULTER DNASE B CALIBRATOR | Beckman Coulter, Inc. | 2001-05-10 | 63 | 0 |
| K003941 | ELECSYS HCG STAT CLASET II | Roche Diagnostics Corp. | 2001-01-25 | 35 | 0 |
| K003969 | ELECSYS CA 125 II CALSET | Roche Diagnostics Corp. | 2001-01-12 | 21 | 0 |
| K002760 | ELECSYS DHEA-S CALSET | Roche Diagnostics Corp. | 2000-10-05 | 30 | 0 |
| K002353 | ELECSYS CA 15-3 CALCHECK | Roche Diagnostics Corp. | 2000-08-10 | 8 | 0 |
| K001906 | ELECSYS INSULIN CALSET | Roche Diagnostics Corp. | 2000-07-13 | 21 | 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 |
| K000331 | SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-10 | 50 | 0 |
| K994168 | SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-03 | 55 | 0 |
| K994169 | SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-03 | 55 | 0 |
| K994114 | DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR | Dade Behring, Inc. | 2000-01-20 | 45 | 0 |
| K994325 | SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-01-12 | 21 | 0 |
| K994145 | VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITRO | Ortho-Clinical Diagnostics, Inc. | 1999-12-22 | 14 | 2 |
| K993219 | WAKO BILIRUBIN CALIBRATOR | Wako Chemicals USA, Inc. | 1999-11-09 | 43 | 0 |
| K983640 | SYNCHRON SYSTEMS LIPID CALIBRATOR | Beckman Coulter, Inc. | 1998-12-21 | 66 | 1 |
| K970933 | AUTO HDL CHOLESTEROL CALIBRATOR | Pointe Scientific, Inc., | 1997-05-23 | 71 | 0 |
| K963847 | WAKO DIRECT HDL-C | Wako Chemicals USA, Inc. | 1996-12-24 | 90 | 0 |
| K964475 | CLINICAL BLOOD GAS MIXTURES | Oxarc, Inc. | 1996-12-06 | 29 | 0 |
| K954546 | BLOOD GAS MIXTURE | Liquid Technology Corp. | 1995-12-28 | 90 | 0 |
| K951964 | SYNCHRON ENZYME VALIDATOR SET | Beckman Instruments, Inc. | 1995-06-29 | 63 | 0 |
| K951585 | T-UPTAKE CALIBRATORS | Diagnostic Reagents, Inc. | 1995-06-15 | 70 | 0 |
| K951629 | IMX ESTRADIOL | Abbott Laboratories | 1995-05-17 | 61 | 0 |
| K944701 | CALIBRATORS | Diagnostic Reagents, Inc. | 1994-11-21 | 59 | 0 |
| K940008 | GLYCATED PROTEIN CALIBRATORS | Primus Corp. | 1994-05-09 | 125 | 0 |
| K936201 | URINARY ALBUMIN CALIBRATOR | Dupont Medical Products | 1994-03-11 | 72 | 0 |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | King Diagnostics, Inc. | 1993-08-25 | 152 | 0 |
| K932555 | DC-LINEATE CAT. NO. SE-091 | Diagnostic Chemicals, Ltd. (Usa) | 1993-08-19 | 85 | 0 |
| K930501 | DU PONT ACA NEV/EEV VERIFIER | Dupont Medical Products | 1993-08-09 | 189 | 0 |
| K922646 | REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM | Behring Diagnostics, Inc. | 1993-06-25 | 387 | 0 |
| K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | Analytical Control Systems, Inc. | 1993-06-07 | 129 | 0 |
| K925877 | DC-UIBC-CAL | Diagnostic Chemicals, Ltd. (Usa) | 1993-03-18 | 119 | 0 |
| K924904 | HDL-CHOLESTEROL STANDARD, MODIFICATION | Verichem Laboratories, Inc. | 1993-01-13 | 106 | 0 |
| K922699 | DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-23 | 111 | 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