PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI— 510(k) K001177
Substantially EquivalentEnteric Products, Inc.
FDA 510(k) clearance K001177 for PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI, Substantially Equivalent on 2000-11-13. Applicant: Enteric Products, Inc..
Clearance details
- Applicant
- Enteric Products, Inc.
- Product code
- Code LYR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stony Brook, NY, US
Adverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.