510(k) K052716
K052716 is an FDA 510(k) premarket notification submitted by Otsuka Pharmaceutical Co., Ltd. for the device "RAPIRUN H. PYLORI ANTIBODY DETECTION KIT". The FDA issued a decision of Substantially Equivalent on November 16, 2006. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Otsuka Pharmaceutical Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2006
- Date Received
- September 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Helicobacter Pylori
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type