Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CGR — Predicate Candidate Screening
84 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
136 days90th percentile
84clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025-03-05 | 223 | 2 |
| K223038 | Access Cortisol | Beckman Coulter, Inc. | 2023-02-08 | 132 | 1 |
| K202136 | IDS Cortisol | Immunodiagnostic Systems , Ltd. | 2021-04-13 | 256 | 0 |
| K202826 | IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 | 113 | 0 |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 | 71 | 0 |
| K062626 | CORTISOL ELISA | Ibl-Hamburg GmbH | 2006-12-20 | 106 | 0 |
| K060480 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND C | Ortho-Clinical Diagnostics | 2006-07-03 | 130 | 0 |
| K052359 | IBL CORTISOL LIA TEST KIT | Lehnus & Associates Consulting | 2005-10-03 | 38 | 0 |
| K050202 | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY | Beckman Coulter, Inc. | 2005-02-09 | 12 | 0 |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Nichols Institute Diagnostics | 2004-12-09 | 71 | 0 |
| K010790 | CORTISOL LIA | Kmi Diagnostics, Inc. | 2002-01-29 | 320 | 0 |
| K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MO | Nichols Institute Diagnostics | 1999-02-05 | 46 | 0 |
| K983990 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-29 | 50 | 0 |
| K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | Nichols Institute Diagnostics | 1997-04-08 | 302 | 0 |
| K954733 | ACCESS CORTISOL ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-12-05 | 64 | 1 |
| K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-05-05 | 221 | 0 |
| K943427 | ACE CEDIA CORTISOL ASSAY | Schiapparelli Biosystems, Inc. | 1994-11-28 | 136 | 0 |
| K940221 | ACCESS CORTISOL REAGENTS | Bio-Rad Laboratories, Inc. | 1994-04-26 | 98 | 0 |
| K931177 | SYNELISA CORTISOL | Elias U.S.A., Inc. | 1993-09-27 | 202 | 0 |
| K931409 | IMMULITE CORTISOL | Diagnostic Products Corp. | 1993-05-11 | 53 | 1 |
| K922676 | CORTISOL CHEMILUMINESCENCE ASSAY | Nichols Institute | 1992-07-10 | 36 | 0 |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Serono-Baker Diagnostics, Inc. | 1992-03-02 | 124 | 0 |
| K905473 | UBI MAGIWEL CORTISOL QUANTITATIVE | United Biotech, Inc. | 1991-01-31 | 56 | 0 |
| K903975 | SEROZYME CORTISOL TEST KIT | Serono-Baker Diagnostics, Inc. | 1991-01-23 | 148 | 0 |
| K900485 | ENZYMUN TEST(R) CORTISOL | Boehringer Mannheim Corp. | 1990-05-02 | 90 | 0 |
| K901296 | CEDIA (TM) CORTISOL ASSAY | Microgenics Corp. | 1990-04-03 | 14 | 0 |
| K896451 | MODIFIED CEDIA(TM) CORTISOL ASSAY | Microgenics Corp. | 1989-12-12 | 33 | 0 |
| K895006 | MILENIA(TM) CORTISOL (MKCO1,5) | Diagnostic Products Corp. | 1989-10-23 | 76 | 0 |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | 1989-10-19 | 43 | 0 |
| K884689 | DSL 7800 ACTIVE CORTISOL | Diagnostic Systems Laboratories, Inc. | 1989-02-23 | 107 | 1 |
| K880687 | CORTISOL ENHANCED LUMINESCENCE ASSAY KIT | Amersham Corp. | 1988-03-24 | 31 | 0 |
| K870969 | CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Canadian Bioclinical, Ltd. | 1987-06-22 | 104 | 0 |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Nuclear Diagnostics, Inc. | 1987-06-17 | 9 | 0 |
| K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1986-09-25 | 97 | 0 |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Cambridge Medical Technology | 1986-08-19 | 21 | 0 |
| K852939 | CORTISOL SYSTEM BY EIA | American Bioclinical, Inc. | 1985-08-02 | 23 | 0 |
| K850141 | ACTIVE CORTISOL DSL 2000-SP | Diagnostic Systems Laboratories, Inc. | 1985-02-06 | 23 | 0 |
| K850008 | SOPHEIA/MP CORTISOL EIA KIT | Diagnostic Products Corp. | 1985-02-01 | 30 | 0 |
| K843384 | LEECO CORTISOL-QUANT | Leeco Diagnostics, Inc. | 1984-09-28 | 31 | 0 |
| K843183 | STRATUS CORTISOL FLUOROMETRIC ENZYME | American Dade | 1984-09-17 | 35 | 0 |
| K842957 | CORITSOL PREMIX RIA KIT | Biotecx Laboratories, Inc. | 1984-09-14 | 49 | 0 |
| K841641 | CORNING MAGIC CORTISOL RADIOIMMUNO | Corning Medical & Scientific | 1984-09-04 | 137 | 0 |
| K842365 | CORTI-COTE CORTISOL SOLID PHASE RADIO | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-08-16 | 62 | 0 |
| K842455 | AMER. BIO-SCIENCE LAB CORTISOL REAGENT | American Bio-Science Laboratories | 1984-08-16 | 55 | 0 |
| K842554 | IMMPULSE CORTISOL ASSAY REAGENTS | Aktis Corp. | 1984-08-12 | 41 | 0 |
| K840466 | NML CORTISOL RIA | Nuclear Medical Laboratories, Inc. | 1984-03-30 | 56 | 0 |
| K834219 | PHASE II CORTISOL KIT | Medical & Scientific Designs, Inc. | 1984-02-04 | 61 | 0 |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | Bioclinical Group | 1983-09-12 | 39 | 0 |
| K831141 | EMIT SRD MANUAL CORTISOL ASSAY | Syva Co. | 1983-05-27 | 50 | 0 |
| K830563 | CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK | Sorin Biomedica, Fiat, USA, Inc. | 1983-05-13 | 79 | 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