FDA product code JCN: Control, Cell Counter, Normal And Abnormal
JCN is the FDA product code for control, cell counter, normal and abnormal. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 12 510(k) submissions under JCN, from 7 different applicants. The average 510(k) review took 47 days (median 40). FDA has posted 3 recalls for JCN devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Control, Cell Counter, Normal And Abnormal |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JCN clearance
Top JCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck Laboratories, Inc. | 4 | 1999-11-30 |
| R&D Systems, Inc. | 3 | 1993-12-06 |
| Bio-Rad | 1 | 1994-06-16 |
| Hematronix, Inc. | 1 | 1990-08-22 |
| Unipath , Ltd. | 1 | 1990-08-22 |
2 more applicants have JCN clearances. See the full list in Caduvo.
Most recent JCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993825 | Streck Laboratories, Inc. | PARA TECH PLUS RETICS | 1999-11-30 | 18 |
| K942209 | Bio-Rad | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | 1994-06-16 | 42 |
| K934497 | R&D Systems, Inc. | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | 1993-12-06 | 83 |
| K911582 | Streck Laboratories, Inc. | STAK-CHEX | 1991-05-28 | 50 |
| K902389 | Hematronix, Inc. | TRI-COUNT 16 | 1990-08-22 | 84 |
Recalls for JCN devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-06-04.
| Year | Recalls |
|---|---|
| 2025 | 3 |
Frequently asked questions
What is FDA product code JCN?
JCN is the FDA product code for control, cell counter, normal and abnormal. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is JCN?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCN?
Across 12 cleared submissions the average was 47 days from receipt to decision (median 40).
Which companies have the most JCN clearances?
Streck Laboratories, Inc. (4); R&D Systems, Inc. (3); Bio-Rad (1); Hematronix, Inc. (1); Unipath , Ltd. (1).
Have JCN devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2025-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code JCN
- Run a recall and safety report across every JCN manufacturer
- Watch product code JCN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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