Product code MLE— Immunology
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
- Classification name
- Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5110
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code MLE
FDA has cleared devices under product code MLE between 1995 and 2001, 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
- 2001
- 1999
- 1995
Top applicants under product code MLE
Recent clearances under product code MLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.