IMMUNOREACTIVE ESTRIOL RIA KIT— 510(k) K802754

Name: FDA 510(k) clearance K802754
Creator: U.S. Food and Drug Administration
Published: 1981-01-21

Substantially Equivalent

Microanalytic Research, Inc.

FDA 510(k) clearance K802754 for IMMUNOREACTIVE ESTRIOL RIA KIT, Substantially Equivalent on 1981-01-21. Applicant: Microanalytic Research, Inc.. Device class: 1.

Clearance details

Applicant: Microanalytic Research, Inc.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1980-11-03
Decision date: 1981-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGI

view all

K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1998-03-03
K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA1996-08-23
K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL1996-05-15
K932989 — COAT-A-COUNT FREE ESTRIOL1994-12-19
K944490 — AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT1994-12-09

More clearances from Microanalytic Research, Inc.

view all

K861097 — TRYPSIN RIA KIT1986-05-29
K820741 — MR1 LUTROPIN RIA KIT1982-04-14
K820740 — MR1 FOLLITROPIN RIA KIT1982-04-06
K813516 — MRI TOBRAMYCIN RIA KIT1981-12-29
K812394 — MRI GENTAMICIN RIA KIT1981-09-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.