FDA product code JCG: Fluid, Diluting, Manual Cell
JCG is the FDA product code for fluid, diluting, manual cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under JCG. The average 510(k) review took 41 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Fluid, Diluting, Manual Cell |
| Device class | Class I |
| Regulation | 21 CFR 864.8200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JCG clearance
Top JCG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Distributors, Inc. | 1 | 1989-05-24 |
Most recent JCG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K892658 | Scientific Distributors, Inc. | SDI PREPAX COUNTAPETTE KIT | 1989-05-24 | 41 |
Recalls for JCG devices
openFDA lists no recalls for product code JCG.
Frequently asked questions
What is FDA product code JCG?
JCG is the FDA product code for fluid, diluting, manual cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel.
What device class is JCG?
Class I, regulation 21 CFR 864.8200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCG?
Across 1 cleared submissions the average was 41 days from receipt to decision (median 41).
Which companies have the most JCG clearances?
Scientific Distributors, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JCG
- Run a recall and safety report across every JCG manufacturer
- Watch product code JCG 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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