JCN — Control, Cell Counter, Normal And Abnormal Class II
FDA product code JCN covers "Control, Cell Counter, Normal And Abnormal", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |