Cleared Traditional

AMIZYME-LEISHMANIA SPP. TEST KIT

K842526 · Amico Lab, Inc. · Immunology

Aug 1984

Decision

61d

Days

Class 1

Risk

About This 510(k) Submission

K842526 is an FDA 510(k) clearance for the AMIZYME-LEISHMANIA SPP. TEST KIT, a Reagent, Leishmanii Serological (Class I — General Controls, product code LOO), submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 61 days after receiving the submission on June 28, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number	K842526 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1984
Decision Date	August 28, 1984
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—