Polychaco Indirect Hemagglutination

FDA 510(k) K830870 · Parasitic Disease Consultants

Substantially Equivalent

510(k) numberK830870

Submission

Device name
Polychaco Indirect Hemagglutination
Applicant
Parasitic Disease Consultants
Mchenry, IL, US
Received
March 18, 1983
Decision date
August 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code GMM

510(k)DeviceApplicantDecision
K981263ToxogenGMM · Traditional Instrumentation Laboratory CO08/06/1998SE
K952818Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiGMM · Traditional Pyramid Biological Corp.11/20/1995SE
K851977Hem Ave-Toxo Titration Hemagglutination Test KitGMM · Traditional Si Sero-Immuno Diagnostics, Inc.10/16/1985SE
K851976Hem Ave-Toxo Screening Hemagglutination Test KitGMM · Traditional Si Sero-Immuno Diagnostics, Inc.10/16/1985SE
K802452Toxotest-Mt Eiken KitGMM · Traditional Syn-Kit, Inc.12/18/1980SE
K790460Txocell-Iha Reagent SystemGMM · Traditional Calbiochem-Behring Corp.05/25/1979SE
K771560Toxha TestGMM · Traditional Burroughs Wellcome Co.09/15/1977SE

More from Burroughs Wellcome Co.

510(k)DeviceDecision
K830869Polychaco Indirect ImmunofluorescenceGLZ · Traditional 08/11/1983SE
K831296Polychaco Fia-Abs Test for SyphilisJWL · Traditional 07/26/1983SE

Questions and answers

When was Polychaco Indirect Hemagglutination cleared by the FDA?

Polychaco Indirect Hemagglutination (K830870) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 147 days after the submission was received.

What is the product code of K830870?

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