510(k) K863121
K863121 is an FDA 510(k) premarket notification submitted by Micron Technology, Inc. for the device "PEAK OVULATION PREDICTOR". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter), a Class I device regulated under 21 CFR 862.1485. Micron Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1986
- Date Received
- August 14, 1986
- 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