510(k) K964014
K964014 is an FDA 510(k) premarket notification submitted by Kenlor Industries, Inc. for the device "KENLOR H. PYLORI CONTROL SERUM". The FDA issued a decision of Substantially Equivalent on Mar 3, 1997. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Kenlor Industries, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 1997
- Date Received
- Oct 7, 1996
- 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
- 510(k)