FDA product code GJL: Romanowsky Stains
GJL is the FDA product code for romanowsky stains. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GJL. The average 510(k) review took 52 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Romanowsky Stains |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every GJL clearance
Top GJL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wescor, Inc. | 1 | 1988-04-01 |
Most recent GJL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880544 | Wescor, Inc. | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY | 1988-04-01 | 52 |
Recalls for GJL devices
openFDA lists no recalls for product code GJL.
Frequently asked questions
What is FDA product code GJL?
GJL is the FDA product code for romanowsky stains. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Hematology panel.
What device class is GJL?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GJL?
Across 1 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most GJL clearances?
Wescor, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJL
- Run a recall and safety report across every GJL manufacturer
- Watch product code GJL 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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