510(k) K821956
K821956 is an FDA 510(k) premarket notification submitted by Baker Instructions Corp. for the device "HAEM-C PLUS BLOOD REFERENCE CONTROLS". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. Baker Instructions Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1982
- Date Received
- June 30, 1982
- 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