510(k) K030555
K030555 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A". The FDA issued a decision of Substantially Equivalent on April 11, 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. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2003
- Date Received
- February 21, 2003
- 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