Atlas FDA

CGI

42 FDA 510(k) clearances · Product code

42 daysmedian time to decision
84 days90th percentile
42clearances measured

FDA profile

Official device name
Radioimmunoassay, Estriol
Device class
Class I (low risk)
Regulation
21 CFR 862.1265
Medical specialty
Clinical Chemistry
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721)Bayer Corp.1998-03-03
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875)Diagnostic Systems Laboratories, Inc.1996-08-23
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356)Diagnostic Systems Laboratories, Inc.1996-05-15
COAT-A-COUNT FREE ESTRIOL (K932989)Diagnostic Products Corp.1994-12-19
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (K944490)Wallac OY1994-12-09
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (K920576)Eastman Kodak Company1992-03-23
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359)Immunotech Corp.1990-08-22
IMMPULSE FREE ESTRIOL ASSAY REAGENTS (K860900)Sclavo, Inc.1986-04-28
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (K850787)Nms Pharmaceuticals, Inc.1985-03-26
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (K844767)Biotecx Laboratories, Inc.1985-02-01
TDX TOTAL ESTRIOL (K844511)Abbott Laboratories1985-01-18
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED (K844408)Amersham Corp.1984-12-11
ENDAB ESTRIOL UNCONJUGATED (K840902)Immunotech Corp.1984-04-18
RIANEN ESTRIOL RADIOIMMUNOASSAY KIT (K840301)New England Nuclear1984-03-30
DSL 1900 (K830816)Diagnostic Systems1983-04-12
FREE & TOTAL ESTRIOL KIT (K823202)Diagnostic Products Corp.1982-12-15
MICROMEDIC ESTRIOL RIA KIT (K822578)Micromedic Systems1982-10-26
DSL 1400 (K822314)Diagnostic Systems Laboratories, Inc.1982-09-30
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM (K821678)Micromedic Systems1982-06-24
QUANTIMUNE ESTRIOL RIA (K820728)Bio-Rad1982-04-06
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT (K812768)Diagnostic Products Corp.1982-01-18
QUANTIMUNE ESTRIOL RIA (K811709)Bio-Rad1981-07-10
ESTRIOL KIT (K811380)Cambridge Nuclear Corp.1981-06-09
NATAL-TEC ESTRIOL (K811371)Armkel, LLC1981-05-29
AMERLEX ESTRIOL RIA KIT (K810667)Amersham Corp.1981-03-31
IMMUNOREACTIVE ESTRIOL RIA KIT (K802754)Microanalytic Research, Inc.1981-01-21
QUANTIMUNE E3 RIA (K802944)Bio-Rad1980-12-22
ESTRIOL-SQUIBB RIA KIT (K802455)E. R. Squibb & Sons, Inc.1980-10-31
ARIA II 125- I-ESTRIOL SYSTEM (K801735)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-09-16
ESTRIOL RIA KIT FOR USE WITH GAMMAFLO (K801424)Squibb & Sons, Inc.1980-07-21
TOTAL ESTRIOL RIA KIT (K800036)Amersham Corp.1980-01-21
NORDICLAB TOTAL ESTRIOL RIA TEST (K792189)Nordiclab Intl.1979-11-13
RSL'S ASSAY PROCEDURE QUANTITATION (K791728)Radioassay Systems Laboratories, Inc.1979-09-27
I ESTRIOL (K790008)Cambridge Nuclear Corp.1979-02-26
RIA KIT, GAMMADAB ESTRIOL (K781938)Clinical Assays, Inc.1979-01-10
RIA, QUANTIMUNE E3 (K781850)Bio-Rad1979-01-03
DIRECT ESTRIOL RIA KIT (K781546)Immunalysis Corporation1978-12-04
I-ESTRIOL TEST SET (K781599)Wien Laboratories, Inc.1978-10-17
HUMAN FOLLICLE STIMULATING HORMONE (K780016)Pcl-Ria, Inc.1978-02-03
RIANEN ESTRIOL RIA KIT (K772323)New England Nuclear1978-01-05
UNCONJUGATED ESTRIOL RIA KIT (K772215)Amersham Corp.1977-12-22
RIA-120 AND ESTRIOL REAGENT SYSTEM (K770465)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-06-02

Track CGI automatically

Every clearance here is in the API, with alerts when new ones post.