Polychaco Indirect Immunofluorescence

FDA 510(k) K830869 · Parasitic Disease Consultants

Substantially Equivalent

510(k) numberK830869

Submission

Device name
Polychaco Indirect Immunofluorescence
Applicant
Parasitic Disease Consultants
Mchenry, IL, US
Received
March 18, 1983
Decision date
August 11, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GLZ – Antigens, If, Toxoplasma Gondii
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3780
Specialty
Microbiology

Other 510(k)s with product code GLZ

510(k)DeviceApplicantDecision
K924882Toxoplasma Igm Ifa Test SystemGLZ · Traditional Zeus Scientific, Inc.03/23/1993SE
K880007Toxo Igm TestGLZ · Traditional Gull Laboratories, Inc.03/17/1988SE
K850591Fiax Toxo-M Antibodies Test KitGLZ · Traditional Intl. Diagnostic Technology04/30/1985SE
K844287Adpifa Test for Antibodies to Toxoplasma GondiiGLZ · Traditional Apple Diagnostic Products01/07/1985SE
K842664Anti-Toxoplasma Gondii KitGLZ · Traditional Amico Lab, Inc.08/28/1984SE
K832900Immunoenzyme Test Sys-Detect-Igm AntiGLZ · Traditional Bionetic Laboratory Products11/14/1983SE
K811562Toxoplasmosis Test KitGLZ · Traditional Immuno-Diagnostic Products, Inc.07/16/1981SE
K803134Toxoplasma Gondii Serological ReagentsGLZ · Traditional Microbiological Research Corp.01/29/1981SE
K801720Toxo Bio-Bead Titration KitGLZ · Traditional Litton Bionetics09/16/1980SE
K791618Torch Bio-Bead Screen KitGLZ · Traditional Litton Bionetics11/13/1979SE

More from Litton Bionetics

510(k)DeviceDecision
K830870Polychaco Indirect HemagglutinationGMM · Traditional 08/12/1983SE
K831296Polychaco Fia-Abs Test for SyphilisJWL · Traditional 07/26/1983SE

Questions and answers

When was Polychaco Indirect Immunofluorescence cleared by the FDA?

Polychaco Indirect Immunofluorescence (K830869) received a 510(k) decision of Substantially Equivalent on August 11, 1983, 146 days after the submission was received.

What is the product code of K830869?

The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.