510(k) K874386
K874386 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1987
- Date Received
- October 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Cell Counter, Normal And Abnormal
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type