Cleared Traditional

K923410 - FIAGEN PROGESTERONE
(FDA 510(k) Clearance)

K923410 · Cyberfluor, Inc. · Hematology

Dec 1992

Decision

146d

Days

Class 1

Risk

K923410 is an FDA 510(k) clearance for the FIAGEN PROGESTERONE. This device is classified as a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS).

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on December 3, 1992, 146 days after receiving the submission on July 10, 1992.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number	K923410 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1992
Decision Date	December 03, 1992
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement