FDA product code LKS: Device, Parasite Concentration
LKS is the FDA product code for device, parasite concentration. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel. FDA has cleared 13 510(k) submissions under LKS, from 10 different applicants. The average 510(k) review took 89 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Device, Parasite Concentration |
| Device class | Class I |
| Regulation | 21 CFR 866.2900 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LKS clearance
Top LKS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Para Scientific Co. | 3 | 2002-06-04 |
| Meridian Diagnostics, Inc. | 2 | 1998-04-02 |
| Alpha-Tec Systems, Inc. | 1 | 2006-05-12 |
| Hardy Diagnostics | 1 | 1994-05-17 |
| Medical Chemical Corp. | 1 | 1994-05-09 |
5 more applicants have LKS clearances. See the full list in Caduvo.
Most recent LKS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053257 | Alpha-Tec Systems, Inc. | PARA-PRO FC50 | 2006-05-12 | 171 |
| K021420 | Para Scientific Co. | PARACON II/FECAL CONCENTRATOR II | 2002-06-04 | 32 |
| K980077 | Meridian Diagnostics, Inc. | PARA-PAK SPINCON | 1998-04-02 | 84 |
| K941110 | Hardy Diagnostics | PARAKIT | 1994-05-17 | 71 |
| K941129 | Medical Chemical Corp. | CON-KIT | 1994-05-09 | 61 |
Recalls for LKS devices
openFDA lists no recalls for product code LKS.
Frequently asked questions
What is FDA product code LKS?
LKS is the FDA product code for device, parasite concentration. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel.
What device class is LKS?
Class I, regulation 21 CFR 866.2900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LKS?
Across 13 cleared submissions the average was 89 days from receipt to decision (median 61).
Which companies have the most LKS clearances?
Para Scientific Co. (3); Meridian Diagnostics, Inc. (2); Alpha-Tec Systems, Inc. (1); Hardy Diagnostics (1); Medical Chemical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKS
- Run a recall and safety report across every LKS manufacturer
- Watch product code LKS 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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