Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CHP — Predicate Candidate Screening
50 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
177 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL I | Ibl GmbH | 2004-09-24 | 127 | 0 |
| K973901 | 17 B-ESTRADIOL (ELISA) | Kmi Diagnostics, Inc. | 1997-11-24 | 41 | 0 |
| K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 | 30 | 2 |
| K970386 | ACS ESTADIOL-6 II | Chiron Diagnostics Corp. | 1997-06-04 | 121 | 0 |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 | 26 | 0 |
| K970126 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Bio-Rad Laboratories, Inc. | 1997-02-25 | 42 | 0 |
| K965109 | ELECSYS ESTRADIOL ASSAY | Boehringer Mannheim Corp. | 1997-02-18 | 60 | 0 |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Biomerieux Vitek, Inc. | 1996-02-06 | 56 | 2 |
| K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY | Ciba Corning Diagnostics Corp. | 1995-12-13 | 62 | 0 |
| K953605 | ULTRA-SENSITIVE ESTRADIOL | Diagnostic Systems Laboratories, Inc. | 1995-10-02 | 61 | 0 |
| K951360 | ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO D | Bayer Corp. | 1995-05-02 | 36 | 0 |
| K946199 | AURAFLEX(R) ESTRADIOL | Organon Teknika Corp. | 1995-04-03 | 104 | 0 |
| K943193 | COAT-A-COUNT(R) ESTRADIOL-6 | Diagnostic Products Corp. | 1995-02-23 | 233 | 0 |
| K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY K | Incstar Corp. | 1994-09-07 | 177 | 0 |
| K932926 | IMMULITE ESTRADIOL | Diagnostic Products Corp. | 1994-01-10 | 209 | 0 |
| K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 | 182 | 0 |
| K932084 | AIA-PACK E2 ASSAY | Tosoh Medics, Inc. | 1993-11-09 | 193 | 0 |
| K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1993-10-22 | 98 | 0 |
| K933066 | OPUS ESTRADIOL | Pb Diagnostic Systems, Inc. | 1993-09-08 | 78 | 0 |
| K931740 | COTUBE ESTRADIOL RADIOIMMUNOASSAY | Bio-Rad | 1993-08-16 | 131 | 0 |
| K925498 | VIDAS ESTRADIOL (E2) ASSAY | Biomerieux Vitek, Inc. | 1993-02-12 | 105 | 0 |
| K920047 | IMX ESTRADIOL | Abbott Laboratories | 1992-02-18 | 43 | 0 |
| K913162 | ENZYMUN-TEST ESTRADIOL | Boehringer Mannheim Corp. | 1991-09-27 | 72 | 0 |
| K912917 | MILENIA ESTRADIOL | Diagnostic Products Corp. | 1991-07-30 | 27 | 0 |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-07-25 | 62 | 0 |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-28 | 60 | 0 |
| K910249 | STRATUS ESTRADIOL FLUOREMETRIC ENZYME | Baxter Healthcare Corp | 1991-02-13 | 22 | 0 |
| K902358 | MODIFIED DELFIA ESTRADIOL KIT | Pharmacia, Inc. | 1990-06-18 | 20 | 0 |
| K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-12-27 | 65 | 0 |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | Amersham Corp. | 1989-12-12 | 42 | 0 |
| K890645 | ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT | Serono-Baker Diagnostics, Inc. | 1989-03-08 | 28 | 0 |
| K884105 | AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) | Amersham Corp. | 1988-11-16 | 48 | 0 |
| K882343 | TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT | Terumo Medical Corp. | 1988-07-01 | 24 | 0 |
| K882173 | DELFIA ESTRADIOL KIT | Pharmacia, Inc. | 1988-06-24 | 31 | 0 |
| K873550 | DSL ACTIVE ESTRADIOL RIA (DSL #4300) | Diagnostic Systems Laboratories, Inc. | 1988-02-18 | 171 | 0 |
| K870405 | DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) | Diagnostic Systems Laboratories, Inc. | 1987-06-08 | 125 | 0 |
| K862603 | DOUBLE ANTIBODY ESTRADIOL RIA KIT | Diagnostic Products Corp. | 1986-08-19 | 42 | 0 |
| K861361 | ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE | Serono Diagnostics, Inc. | 1986-06-27 | 78 | 0 |
| K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS | Pantex, Div. Bio-Analysis, Inc. | 1985-10-15 | 28 | 0 |
| K853208 | 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY | Travenol Laboratories, S.A. | 1985-08-19 | 19 | 0 |
| K851540 | ESTRADIOL DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1985-06-06 | 51 | 0 |
| K841947 | ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT | Sorin Biomedica, Fiat, USA, Inc. | 1984-06-25 | 42 | 0 |
| K840051 | COAT-A-COUNT ESTRADIOL KIT | Diagnostic Products Corp. | 1984-03-23 | 77 | 0 |
| K834586 | LEECO E2 QUANT DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1984-03-09 | 71 | 0 |
| K820329 | ESTRADIOL KIT BY RIA | Immuchem Corp. | 1982-03-04 | 24 | 0 |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1981-03-31 | 15 | 0 |
| K810204 | 17B ESTRADIOL | Pantex, Div. Bio-Analysis, Inc. | 1981-03-27 | 60 | 0 |
| K800920 | NORDICLAB ESTRADIOL RIA TEST | Nordiclab Intl. | 1980-05-14 | 23 | 0 |
| K791652 | ESTRADIOL KIT BY RIA | Radioassay Systems Laboratories, Inc. | 1979-09-27 | 37 | 0 |
| K790679 | ESTRADIOL RIA KIT | Serono Laboratories, Inc. | 1979-05-23 | 44 | 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