Cleared Traditional

K811562 - TOXOPLASMOSIS TEST KIT
(FDA 510(k) Clearance)

K811562 · Immuno-Diagnostic Products, Inc. · Microbiology

Jul 1981

Decision

43d

Days

Class 2

Risk

K811562 is an FDA 510(k) clearance for the TOXOPLASMOSIS TEST KIT. This device is classified as a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ).

Submitted by Immuno-Diagnostic Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981, 43 days after receiving the submission on June 3, 1981.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K811562 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1981
Decision Date	July 16, 1981
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—