FDA product code JCE: Solution, Isotonic
JCE is the FDA product code for solution, isotonic. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under JCE, from 6 different applicants. The average 510(k) review took 39 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Isotonic |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JCE clearance
Top JCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio/Data Corp. | 2 | 1977-01-10 |
| E K Ind., Inc. | 1 | 1984-09-11 |
| Emd Chemicals, Inc. | 1 | 1983-05-09 |
| Nobel Scientific Industries, Inc. | 1 | 1980-07-28 |
| Coulter Electronics, Inc. | 1 | 1979-11-20 |
1 more applicants have JCE clearances. See the full list in Caduvo.
Most recent JCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842722 | E K Ind., Inc. | BUFFERED SALINE | 1984-09-11 | 60 |
| K831200 | Emd Chemicals, Inc. | IMMUNOHEMATOLOGICAL SALINE #97139 | 1983-05-09 | 28 |
| K801506 | Nobel Scientific Industries, Inc. | CERTIFIED BLOOD BANK SALINE | 1980-07-28 | 28 |
| K792101 | Coulter Electronics, Inc. | COUITER/CMS ISOTONIC BLOOD BANK SALINE | 1979-11-20 | 32 |
| K761183 | Central Labs. Assoc. MD Pathologists | LYSING AGENT AF | 1977-01-17 | 46 |
Recalls for JCE devices
openFDA lists no recalls for product code JCE.
Frequently asked questions
What is FDA product code JCE?
JCE is the FDA product code for solution, isotonic. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is JCE?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCE?
Across 7 cleared submissions the average was 39 days from receipt to decision (median 40).
Which companies have the most JCE clearances?
Bio/Data Corp. (2); E K Ind., Inc. (1); Emd Chemicals, Inc. (1); Nobel Scientific Industries, Inc. (1); Coulter Electronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JCE
- Run a recall and safety report across every JCE manufacturer
- Watch product code JCE 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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