510(k) K002023
K002023 is an FDA 510(k) premarket notification submitted by Medmira Laboratories, Inc. for the device "MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714". The FDA issued a decision of Substantially Equivalent on Nov 13, 2000. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 2000
- Date Received
- Jul 3, 2000
- 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)