FDA product code LSK: Dna-Reagents, Chlamydia
LSK is the FDA product code for dna-reagents, chlamydia. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under LSK, from 3 different applicants. The average 510(k) review took 252 days (median 182). FDA has posted 1 recall for LSK devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Chlamydia |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| 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 LSK clearance
Top LSK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 4 | 1994-04-06 |
| Digene Corp. | 3 | 2001-09-25 |
| Abbott Molecular, Inc. | 1 | 2010-05-28 |
Most recent LSK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092704 | Abbott Molecular, Inc. | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 | 2010-05-28 | 267 |
| K010891 | Digene Corp. | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | 2001-09-25 | 183 |
| K010892 | Digene Corp. | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | 2001-09-24 | 182 |
| K990023 | Digene Corp. | HYBRID CAPTURE II CT-ID TEST | 1999-10-25 | 293 |
| K920302 | Gen-Probe, Inc. | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY | 1994-04-06 | 806 |
Recalls for LSK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-20.
Frequently asked questions
What is FDA product code LSK?
LSK is the FDA product code for dna-reagents, chlamydia. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is LSK?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code LSK?
Across 8 cleared submissions the average was 252 days from receipt to decision (median 182).
Which companies have the most LSK clearances?
Gen-Probe, Inc. (4); Digene Corp. (3); Abbott Molecular, Inc. (1).
Have LSK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LSK
- Run a recall and safety report across every LSK manufacturer
- Watch product code LSK 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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