510(k) K014038
K014038 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "PYLORITEK VP TEST KIT 5140VP". The FDA issued a decision of Substantially Equivalent on February 8, 2002. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Serim Research Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2002
- Date Received
- December 7, 2001
- 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