Cleared Traditional

ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII

K844287 · Apple Diagnostic Products · Microbiology

Jan 1985

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K844287 is an FDA 510(k) clearance for the ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Apple Diagnostic Products (Pipersille, US). The FDA issued a Cleared decision on January 7, 1985, 63 days after receiving the submission on November 5, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K844287 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1984
Decision Date	January 07, 1985
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—