510(k) K854823
K854823 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "CBC-CAL/MULTIPLE". The FDA issued a decision of Substantially Equivalent on February 13, 1986. The device falls under product code KSA (Calibrator For Red-Cell And White-Cell Counting), a Class II device regulated under 21 CFR 864.8185. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1986
- Date Received
- December 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator For Red-Cell And White-Cell Counting
- Device Class
- Class II
- Regulation Number
- 864.8185
- Review Panel
- HE
- Submission Type