Cleared Traditional

K841302 - DIAGNON FOLATE 125I RIA KIT
(FDA 510(k) Clearance)

K841302 · Diagnon Corp. · Chemistry

Jun 1984

Decision

84d

Days

Class 2

Risk

K841302 is an FDA 510(k) clearance for the DIAGNON FOLATE 125I RIA KIT, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Diagnon Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984, 84 days after receiving the submission on March 30, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number	K841302 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 1984
Decision Date	June 22, 1984
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—