JCN
12 FDA 510(k) clearances · Product code
42 daysmedian time to decision
84 days90th percentile
12clearances measured
FDA profile
- Official device name
- Control, Cell Counter, Normal And Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PARA TECH PLUS RETICS (K993825) | Streck Laboratories, Inc. | 1999-11-30 |
| LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (K942209) | Bio-Rad | 1994-06-16 |
| CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE (K934497) | R&D Systems, Inc. | 1993-12-06 |
| STAK-CHEX (K911582) | Streck Laboratories, Inc. | 1991-05-28 |
| CELL-DYN 3000 CONTROL (K902391) | Unipath , Ltd. | 1990-08-22 |
| TRI-COUNT 16 (K902389) | Hematronix, Inc. | 1990-08-22 |
| PARA 12 PLUS (K901875) | Streck Laboratories, Inc. | 1990-05-30 |
| PARA TECH FOR TECHNICON H-1 (K896154) | Streck Laboratories, Inc. | 1989-11-09 |
| HEMATOLOGY CONTROL (K895373) | Medical Specialties Intl., Inc. | 1989-10-06 |
| QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (K891907) | R&D Systems, Inc. | 1989-04-11 |
| CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (K874386) | R&D Systems, Inc. | 1987-12-30 |
| HAEM-C PLUS BLOOD REFERENCE CONTROLS (K821956) | Baker Instructions Corp. | 1982-07-30 |
Track JCN automatically
Every clearance here is in the API, with alerts when new ones post.