510(k) K963693
K963693 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST". The FDA issued a decision of Substantially Equivalent on Nov 29, 1996. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 29, 1996
- Date Received
- Sep 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Luteinizing Hormone
- Device Class
- Class I
- Regulation Number
- 862.1485
- Review Panel
- CH
- Submission Type