510(k) K900280
K900280 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "CENTRIPREP 100". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code JJP (Electrode, Ion Selective (Non-Specified)), a Class I device regulated under 21 CFR 862.2050. Amicon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1990
- Date Received
- January 18, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Selective (Non-Specified)
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type