Product code GMN— Microbiology
AGGLUTINOTEST-TOXOPLASMOSIS
- Classification name
- Antigens, Cf, Toxoplasma Gondii
- Device class
- Class 2
- Regulation
- 21 CFR 866.3780
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GMN
FDA has cleared devices under product code GMN between 1979 and 1989, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1989
- 1987
- 1979
Top applicants under product code GMN
Recent clearances under product code GMN
Data sourced from openFDA. This site is unofficial and independent of the FDA.