Product code JCN— Hematology
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
- Classification name
- Control, Cell Counter, Normal And Abnormal
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code JCN
FDA has cleared devices under product code JCN between 1982 and 1999, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1999
- 1994
- 1993
- 1991
- 1990
- 1989
- 1987
- 1982
Top applicants under product code JCN
Recent clearances under product code JCN
- K993825 — PARA TECH PLUS RETICS
- K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
- K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
- K911582 — STAK-CHEX
- K902389 — TRI-COUNT 16
- K902391 — CELL-DYN 3000 CONTROL
- K901875 — PARA 12 PLUS
- K896154 — PARA TECH FOR TECHNICON H-1
- K895373 — HEMATOLOGY CONTROL
- K891907 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
- K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
- K821956 — HAEM-C PLUS BLOOD REFERENCE CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.