MODIFIED COTROPIN RADIOIMMUNOASSAY KIT— 510(k) K862180

Name: FDA 510(k) clearance K862180
Creator: U.S. Food and Drug Administration
Published: 1986-07-07

Substantially Equivalent

Clinetics Corp.

FDA 510(k) clearance K862180 for MODIFIED COTROPIN RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1986-07-07. Applicant: Clinetics Corp.. Device class: 1.

Clearance details

Applicant: Clinetics Corp.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1986-06-09
Decision date: 1986-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEP

view all

K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE2003-01-16
K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST2002-11-05
K021409 — AT HOME OVULATION TEST, MODEL 90322002-05-24
K013874 — CLEARPLANE EASY OVULATION TEST2002-02-19
K013323 — TCI-31 LIFELONG OVULATION TESTER2001-12-05

More clearances from Clinetics Corp.

view all

K844066 — COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH1985-01-18
K841580 — TSH RECEPTOR ANTIBODY KIT 125I TSH1984-10-22
K833934 — ADRENOCORTICOTROPIC HORMONE TEST1984-04-04
K830357 — RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E1983-03-17
K823379 — 125-I FSH RADIOIMMUNOASSAY KIT1982-12-22

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