510(k) K024080
K024080 is an FDA 510(k) premarket notification submitted by Perfusion Partners & Assoc., Inc. for the device "SECQUIRE CELL SEPARATOR". The FDA issued a decision of Substantially Equivalent on July 2, 2003. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Perfusion Partners & Assoc., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2003
- Date Received
- December 10, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type