510(k) K861188
K861188 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "SPERM CAPACITATION MEDIUM". The FDA issued a decision of Substantially Equivalent on January 6, 1987. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Irvine Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1987
- Date Received
- March 31, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type