FDA product code LGY: Trypan Blue
LGY is the FDA product code for trypan blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under LGY. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Trypan Blue |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LGY clearance
Top LGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dutchland Laboratories, Inc. | 1 | 1981-05-13 |
Most recent LGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810782 | Dutchland Laboratories, Inc. | TRYPAN BLUE (0.5% IN NORMAL SALINE) | 1981-05-13 | 51 |
Recalls for LGY devices
openFDA lists no recalls for product code LGY.
Frequently asked questions
What is FDA product code LGY?
LGY is the FDA product code for trypan blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is LGY?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LGY?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most LGY clearances?
Dutchland Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGY
- Run a recall and safety report across every LGY manufacturer
- Watch product code LGY 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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