FDA product code LDY: Fixative, Formalin-Containing
LDY is the FDA product code for fixative, formalin-containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under LDY. The average 510(k) review took 52 days (median 52). FDA has posted 7 recalls for LDY devices.
Classification
| Field | Value |
|---|---|
| Device name | Fixative, Formalin-Containing |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top LDY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytocorp, Inc. | 1 | 1988-04-01 |
Most recent LDY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880549 | Cytocorp, Inc. | DIACYTE FIXATIVE SOLUTION | 1988-04-01 | 52 |
Recalls for LDY devices
7 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-09-17.
Frequently asked questions
What is FDA product code LDY?
LDY is the FDA product code for fixative, formalin-containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is LDY?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDY?
Across 1 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most LDY clearances?
Cytocorp, Inc. (1).
Have LDY devices been recalled?
Yes: 7 product recalls across 1 recall events; the most recent began 2014-09-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LDY
- Run a recall and safety report across every LDY manufacturer
- Watch product code LDY 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.