510(k) K894651
K894651 is an FDA 510(k) premarket notification submitted by Coulter Corp. for the device "COULTER POSITIVE CONTROL CELLS". The FDA issued a decision of Substantially Equivalent on September 13, 1989. The device falls under product code GGL (Control, White-Cell), a Class II device regulated under 21 CFR 864.8625. Coulter Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1989
- Date Received
- July 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, White-Cell
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type