RAPIRUN H. PYLORI ANTIBODY DETECTION KIT— 510(k) K052716
Substantially EquivalentOtsuka Pharmaceutical Co., Ltd.
FDA 510(k) clearance K052716 for RAPIRUN H. PYLORI ANTIBODY DETECTION KIT, Substantially Equivalent on 2006-11-16. Applicant: Otsuka Pharmaceutical Co., Ltd..
Clearance details
- Applicant
- Otsuka Pharmaceutical Co., Ltd.
- Product code
- Code LYR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, 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.