FDA product code LTC: Hyaline Membrane Disease Assay
LTC is the FDA product code for hyaline membrane disease assay. It is a Class III device, reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under LTC. The average 510(k) review took 203 days (median 203).
Classification
| Field | Value |
|---|---|
| Device name | Hyaline Membrane Disease Assay |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LTC clearance
Top LTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dow Corning Corp. Healthcare Industries Materials | 1 | 1985-06-19 |
Most recent LTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844637 | Dow Corning Corp. Healthcare Industries Materials | WHITESIDE ACRYLIC CEMENT SPACER SLEEVE | 1985-06-19 | 203 |
Recalls for LTC devices
openFDA lists no recalls for product code LTC.
Frequently asked questions
What is FDA product code LTC?
LTC is the FDA product code for hyaline membrane disease assay. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is LTC?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LTC?
Across 1 cleared submissions the average was 203 days from receipt to decision (median 203).
Which companies have the most LTC clearances?
Dow Corning Corp. Healthcare Industries Materials (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LTC
- Run a recall and safety report across every LTC manufacturer
- Watch product code LTC 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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