510(k) K973860
K973860 is an FDA 510(k) premarket notification submitted by Conception Technology, Inc. for the device "OVULON MONITOR". The FDA issued a decision of Substantially Equivalent on January 7, 1998. The device falls under product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter), a Class I device regulated under 21 CFR 862.1485. Conception Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1998
- Date Received
- October 9, 1997
- 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