FDA product code LKC: Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus
LKC is the FDA product code for antigens, indirect hemagglutination (iha) herpes simplex virus. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. Devices under LKC reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for LKC devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for LKC devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-05.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code LKC?
LKC is the FDA product code for antigens, indirect hemagglutination (iha) herpes simplex virus. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is LKC?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
Have LKC devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2017-05-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LKC
- Run a recall and safety report across every LKC manufacturer
- Watch product code LKC 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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