FDA product code KLH: Antisera, C. Acnes
KLH is the FDA product code for antisera, c. acnes. It is a Class I device, regulated under 21 CFR 866.3140 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under KLH. The average 510(k) review took 9 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, C. Acnes |
| Device class | Class I |
| Regulation | 21 CFR 866.3140 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KLH clearance
Top KLH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thoracel | 1 | 1980-08-13 |
Most recent KLH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801858 | Thoracel | OXYMETER & TRANSOXODE | 1980-08-13 | 9 |
Recalls for KLH devices
openFDA lists no recalls for product code KLH.
Frequently asked questions
What is FDA product code KLH?
KLH is the FDA product code for antisera, c. acnes. It is a Class I device, regulated under 21 CFR 866.3140 and reviewed by the Microbiology panel.
What device class is KLH?
Class I, regulation 21 CFR 866.3140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KLH?
Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most KLH clearances?
Thoracel (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KLH
- Run a recall and safety report across every KLH manufacturer
- Watch product code KLH 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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