FDA Product Code
FDA Product Code CGI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1265
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974721 | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1998-03-03 | Traditional | PDF ↗ |
| K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-23 | Traditional | PDF ↗ |
| K955356 | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL | Diagnostic Systems Laboratories, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K932989 | COAT-A-COUNT FREE ESTRIOL | Diagnostic Products Corp. | 1994-12-19 | Traditional | PDF ↗ |
| K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | Wallac OY | 1994-12-09 | Traditional | PDF ↗ |
| K920576 | AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL | Eastman Kodak Company | 1992-03-23 | Traditional | PDF ↗ |
| K903359 | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT | Immunotech Corp. | 1990-08-22 | Traditional | PDF ↗ |
| K860900 | IMMPULSE FREE ESTRIOL ASSAY REAGENTS | Sclavo, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | 1985-03-26 | Traditional | PDF ↗ |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | Biotecx Laboratories, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K844511 | TDX TOTAL ESTRIOL | Abbott Laboratories | 1985-01-18 | Traditional | PDF ↗ |
| K844408 | AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED | Amersham Corp. | 1984-12-11 | Traditional | PDF ↗ |
| K840902 | ENDAB ESTRIOL UNCONJUGATED | Immunotech Corp. | 1984-04-18 | Traditional | PDF ↗ |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | New England Nuclear | 1984-03-30 | Traditional | PDF ↗ |
| K830816 | DSL 1900 | Diagnostic Systems | 1983-04-12 | Traditional | PDF ↗ |
| K823202 | FREE & TOTAL ESTRIOL KIT | Diagnostic Products Corp. | 1982-12-15 | Traditional | PDF ↗ |
| K822578 | MICROMEDIC ESTRIOL RIA KIT | Micromedic Systems | 1982-10-26 | Traditional | PDF ↗ |
| K822314 | DSL 1400 | Diagnostic Systems Laboratories, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821678 | AUTOPAK ESTRIOL TEST DELIVERY SYSTEM | Micromedic Systems | 1982-06-24 | Traditional | PDF ↗ |
| K820728 | QUANTIMUNE ESTRIOL RIA | Bio-Rad | 1982-04-06 | Traditional | PDF ↗ |
| K812768 | COAT-A-COUNT FREE & TOTAL ESTRIOL KIT | Diagnostic Products Corp. | 1982-01-18 | Traditional | PDF ↗ |
| K811709 | QUANTIMUNE ESTRIOL RIA | Bio-Rad | 1981-07-10 | Traditional | PDF ↗ |
| K811380 | ESTRIOL KIT | Cambridge Nuclear Corp. | 1981-06-09 | Traditional | PDF ↗ |
| K811371 | NATAL-TEC ESTRIOL | Armkel, LLC | 1981-05-29 | Traditional | PDF ↗ |
| K810667 | AMERLEX ESTRIOL RIA KIT | Amersham Corp. | 1981-03-31 | Traditional | PDF ↗ |
| K802754 | IMMUNOREACTIVE ESTRIOL RIA KIT | Microanalytic Research, Inc. | 1981-01-21 | Traditional | PDF ↗ |
| K802944 | QUANTIMUNE E3 RIA | Bio-Rad | 1980-12-22 | Traditional | PDF ↗ |
| K802455 | ESTRIOL-SQUIBB RIA KIT | E. R. Squibb & Sons, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801735 | ARIA II 125- I-ESTRIOL SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-09-16 | Traditional | PDF ↗ |
| K801424 | ESTRIOL RIA KIT FOR USE WITH GAMMAFLO | Squibb & Sons, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K800036 | TOTAL ESTRIOL RIA KIT | Amersham Corp. | 1980-01-21 | Traditional | PDF ↗ |
| K792189 | NORDICLAB TOTAL ESTRIOL RIA TEST | Nordiclab Intl. | 1979-11-13 | Traditional | PDF ↗ |
| K791728 | RSL'S ASSAY PROCEDURE QUANTITATION | Radioassay Systems Laboratories, Inc. | 1979-09-27 | Traditional | PDF ↗ |
| K790008 | I ESTRIOL | Cambridge Nuclear Corp. | 1979-02-26 | Traditional | PDF ↗ |
| K781938 | RIA KIT, GAMMADAB ESTRIOL | Clinical Assays, Inc. | 1979-01-10 | Traditional | PDF ↗ |
| K781850 | RIA, QUANTIMUNE E3 | Bio-Rad | 1979-01-03 | Traditional | PDF ↗ |
| K781546 | DIRECT ESTRIOL RIA KIT | Immunalysis Corporation | 1978-12-04 | Traditional | PDF ↗ |
| K781599 | I-ESTRIOL TEST SET | Wien Laboratories, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K780016 | HUMAN FOLLICLE STIMULATING HORMONE | Pcl-Ria, Inc. | 1978-02-03 | Traditional | PDF ↗ |
| K772323 | RIANEN ESTRIOL RIA KIT | New England Nuclear | 1978-01-05 | Traditional | PDF ↗ |
| K772215 | UNCONJUGATED ESTRIOL RIA KIT | Amersham Corp. | 1977-12-22 | Traditional | PDF ↗ |
| K770465 | RIA-120 AND ESTRIOL REAGENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-02 | Traditional | PDF ↗ |
Product code CGI · Class I · Clinical Chemistry. Data: openFDA.