Cleared Traditional

K822941 - NETILMICIN FLUORESCENT IMMUNOASSAY
(FDA 510(k) Clearance)

K822941 · American Diagnostic Corp. · Chemistry

Oct 1982

Decision

22d

Days

Class 2

Risk

K822941 is an FDA 510(k) clearance for the NETILMICIN FLUORESCENT IMMUNOASSAY. This device is classified as a Radioimmunoassay, Netilmicin (i-125) (Class II — Special Controls, product code LCE).

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1982, 22 days after receiving the submission on October 4, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number	K822941 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 1982
Decision Date	October 26, 1982
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—