510(k) K884807
K884807 is an FDA 510(k) premarket notification submitted by Statspin Technologies for the device "LIPOCLEAR LIPEMIA CLEARING REAGENT". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Statspin Technologies has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1989
- Date Received
- November 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type