FDA product code LOP: Solution, Antimicrobial
LOP is the FDA product code for solution, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under LOP, from 2 different applicants. The average 510(k) review took 29 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Antimicrobial |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LOP clearance
Top LOP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Upjohn Co. | 2 | 1990-05-15 |
| Cathra International, Inc. | 1 | 1981-04-01 |
Most recent LOP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902004 | The Upjohn Co. | TROBICIN SUSCEPTIBILITY POWDER | 1990-05-15 | 39 |
| K900455 | The Upjohn Co. | ZEFAZONE SUSCEPTIBILITY POWDER | 1990-02-09 | 10 |
| K810471 | Cathra International, Inc. | STOCK ANTIMICROBIC SOLUTIONS | 1981-04-01 | 37 |
Recalls for LOP devices
openFDA lists no recalls for product code LOP.
Frequently asked questions
What is FDA product code LOP?
LOP is the FDA product code for solution, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is LOP?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code LOP?
Across 3 cleared submissions the average was 29 days from receipt to decision (median 37).
Which companies have the most LOP clearances?
The Upjohn Co. (2); Cathra International, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LOP
- Run a recall and safety report across every LOP manufacturer
- Watch product code LOP 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times