FDA product code LKA: Culture Media, Antimicrobial Susceptibility Test
LKA is the FDA product code for culture media, antimicrobial susceptibility test. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under LKA, from 2 different applicants. The average 510(k) review took 36 days (median 35). FDA has posted 5 recalls for LKA devices.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Antimicrobial Susceptibility Test |
| Device class | Class II |
| Regulation | 21 CFR 866.1700 |
| 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 LKA clearance
Top LKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| I.A.F. Production, Inc. | 3 | 1987-08-11 |
| Acumedia Manufacturers, Inc. | 2 | 1983-10-27 |
Most recent LKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872686 | I.A.F. Production, Inc. | IAFP MUELLER HINTON AGAR | 1987-08-11 | 35 |
| K872688 | I.A.F. Production, Inc. | IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD | 1987-08-11 | 35 |
| K872687 | I.A.F. Production, Inc. | IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT | 1987-08-11 | 35 |
| K833207 | Acumedia Manufacturers, Inc. | AK AGAR 2 | 1983-10-27 | 38 |
| K833218 | Acumedia Manufacturers, Inc. | YEAST BEEF AGAR-ANTIBIOTIC MED.4 | 1983-10-27 | 38 |
Recalls for LKA devices
5 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-02-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LKA?
LKA is the FDA product code for culture media, antimicrobial susceptibility test. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel.
What device class is LKA?
Class II, regulation 21 CFR 866.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKA?
Across 5 cleared submissions the average was 36 days from receipt to decision (median 35).
Which companies have the most LKA clearances?
I.A.F. Production, Inc. (3); Acumedia Manufacturers, Inc. (2).
Have LKA devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2017-02-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LKA
- Run a recall and safety report across every LKA manufacturer
- Watch product code LKA 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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