GMMClass II

Antigens, Iha, Toxoplasma Gondii

21 CFR 866.3780 / Microbiology

GMM is the FDA product code for Antigens, Iha, Toxoplasma Gondii, a class II device type, regulated under 21 CFR 866.3780. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 1998-08-06, and no recalls.

Classification record

Product code: GMM
Device name: Antigens, Iha, Toxoplasma Gondii
Regulation: 21 CFR 866.3780
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 8
Ingested recalls: 0

Clearances, product code GMM

By decision year

8 clearances under product code GMM with a decision year between 1977 and 1998, 1985 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code GMM by decision year
Year	Clearances
1977	1
1979	1
1980	1
1983	1
1985	2
1995	1
1998	1

Applicants with the most clearances

Product code GMM

Applicants holding the most 510(k) clearances under product code GMM
Applicant	Clearances
Si Sero-Immuno Diagnostics, Inc.	2
Burroughs Wellcome Co.	1
Calbiochem-Behring Corp.	1
Instrumentation Laboratory Co.	1
Parasitic Disease Consultants	1
Pyramid Biological Corp.	1
Syn-Kit, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GMM.