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CGI — Radioimmunoassay, Estriol Class I

FDA Device Classification

Classification Details

Product Code
CGI
Device Class
Class I
Regulation Number
862.1265
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K974721bayerUNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYMarch 3, 1998
K962875diagnostic systems laboratoriesACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIAAugust 23, 1996
K955356diagnostic systems laboratoriesACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLMay 15, 1996
K932989diagnostic productsCOAT-A-COUNT FREE ESTRIOLDecember 19, 1994
K944490wallacAUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITDecember 9, 1994
K920576eastman kodakAMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLMarch 23, 1992
K903359immunotechMICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KITAugust 22, 1990
K860900sclavoIMMPULSE FREE ESTRIOL ASSAY REAGENTSApril 28, 1986
K850787nms pharmaceuticalsSOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAYMarch 26, 1985
K844767biotecx laboratoriesRADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TOFebruary 1, 1985
K844511abbott laboratoriesTDX TOTAL ESTRIOLJanuary 18, 1985
K844408amershamAMERLEX-M SPECIFIC ESTRIOL UNCONJUGATEDDecember 11, 1984
K840902immunotechENDAB ESTRIOL UNCONJUGATEDApril 18, 1984
K840301new england nuclearRIANEN ESTRIOL RADIOIMMUNOASSAY KITMarch 30, 1984
K830816diagnostic systemsDSL 1900April 12, 1983
K823202diagnostic productsFREE & TOTAL ESTRIOL KITDecember 15, 1982
K822578micromedic systemsMICROMEDIC ESTRIOL RIA KITOctober 26, 1982
K822314diagnostic systems laboratoriesDSL 1400September 30, 1982
K821678micromedic systemsAUTOPAK ESTRIOL TEST DELIVERY SYSTEMJune 24, 1982
K820728bio-radQUANTIMUNE ESTRIOL RIAApril 6, 1982