JCN — Control, Cell Counter, Normal And Abnormal Class II
FDA Device Classification
Classification Details
- Product Code
- JCN
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K993825 | streck laboratories | PARA TECH PLUS RETICS | November 30, 1999 |
| K942209 | bio-rad | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | June 16, 1994 |
| K934497 | r and d systems | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | December 6, 1993 |
| K911582 | streck laboratories | STAK-CHEX | May 28, 1991 |
| K902391 | unipath | CELL-DYN 3000 CONTROL | August 22, 1990 |
| K902389 | hematronix | TRI-COUNT 16 | August 22, 1990 |
| K901875 | streck laboratories | PARA 12 PLUS | May 30, 1990 |
| K896154 | streck laboratories | PARA TECH FOR TECHNICON H-1 | November 9, 1989 |
| K895373 | medical specialties intl | HEMATOLOGY CONTROL | October 6, 1989 |
| K891907 | r and d systems | QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED | April 11, 1989 |
| K874386 | r and d systems | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | December 30, 1987 |
| K821956 | baker instructions | HAEM-C PLUS BLOOD REFERENCE CONTROLS | July 30, 1982 |