Cleared Traditional

K802877 - AMIKACIN RIA KIT
(FDA 510(k) Clearance)

K802877 · Antibodies, Inc. · Chemistry

Dec 1980

Decision

32d

Days

Class 2

Risk

K802877 is an FDA 510(k) clearance for the AMIKACIN RIA KIT, a Radioimmunoassay, Amikacin (Class II — Special Controls, product code KLQ), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1980, 32 days after receiving the submission on November 17, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3035.

Submission Details

510(k) Number	K802877 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1980
Decision Date	December 19, 1980
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—