510(k) K020808
K020808 is an FDA 510(k) premarket notification submitted by Pheromone Sciences Corp. for the device "FERTILITE OV". The FDA issued a decision of Substantially Equivalent on September 23, 2002. The device falls under product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter), a Class I device regulated under 21 CFR 862.1485.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2002
- Date Received
- March 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Luteinizing Hormone (Lh), Over The Counter
- Device Class
- Class I
- Regulation Number
- 862.1485
- Review Panel
- TX
- Submission Type