FDA product code LKT: Respiratory Syncytial Virus, Antigen, Antibody, Ifa
LKT is the FDA product code for respiratory syncytial virus, antigen, antibody, ifa. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel. FDA has cleared 23 510(k) submissions under LKT, from 18 different applicants. The average 510(k) review took 101 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Device class | Class I |
| Regulation | 21 CFR 866.3480 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LKT clearance
Top LKT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 2 | 1999-03-18 |
| Gull Laboratories, Inc. | 2 | 1991-12-09 |
| Baxter Diagnostics, Inc. | 2 | 1991-09-27 |
| Genetic Systems Corp. | 2 | 1987-11-20 |
| Ortho Diagnostic Systems, Inc. | 2 | 1984-10-05 |
13 more applicants have LKT clearances. See the full list in Caduvo.
Most recent LKT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081928 | Diagnostic Hybrids, Inc. | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | 2008-12-23 | 169 |
| K983336 | Diagnostic Products Corp. | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 | 1999-03-18 | 176 |
| K943317 | Diagnostic Products Corp. | PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) | 1994-12-19 | 161 |
| K942173 | Neogenex | RSV ANTIGEN TEST | 1994-06-30 | 56 |
| K912842 | Gull Laboratories, Inc. | RSV-MAB TEST | 1991-12-09 | 166 |
Recalls for LKT devices
openFDA lists no recalls for product code LKT.
Frequently asked questions
What is FDA product code LKT?
LKT is the FDA product code for respiratory syncytial virus, antigen, antibody, ifa. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel.
What device class is LKT?
Class I, regulation 21 CFR 866.3480. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LKT?
Across 23 cleared submissions the average was 101 days from receipt to decision (median 91).
Which companies have the most LKT clearances?
Diagnostic Products Corp. (2); Gull Laboratories, Inc. (2); Baxter Diagnostics, Inc. (2); Genetic Systems Corp. (2); Ortho Diagnostic Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LKT
- Run a recall and safety report across every LKT manufacturer
- Watch product code LKT 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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