510(k) K981396
K981396 is an FDA 510(k) premarket notification submitted by Amdl, Inc. for the device "PYLORIPROBE". The FDA issued a decision of Substantially Equivalent on July 30, 1998. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Amdl, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1998
- Date Received
- April 17, 1998
- 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