510(k) K012252
K012252 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "QUIK-CHECK OVULATION PREDICTOR". The FDA issued a decision of Substantially Equivalent on Aug 24, 2001. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. ACON Laboratories, Inc. has 92 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 24, 2001
- Date Received
- Jul 18, 2001
- 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
- 510(k) Exempt