LKA — Culture Media, Antimicrobial Susceptibility Test Class II
FDA product code LKA covers "Culture Media, Antimicrobial Susceptibility Test", a Class II medical device regulated under 21 CFR 866.1700. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKA
- Device Class
- Class II
- Regulation Number
- 866.1700
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K872687 | i.a.f. production | IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT | August 11, 1987 |
| K872688 | i.a.f. production | IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD | August 11, 1987 |
| K872686 | i.a.f. production | IAFP MUELLER HINTON AGAR | August 11, 1987 |
| K833207 | acumedia manufacturers | AK AGAR 2 | October 27, 1983 |
| K833218 | acumedia manufacturers | YEAST BEEF AGAR-ANTIBIOTIC MED.4 | October 27, 1983 |