LTW — Susceptibility Test Cards, Antimicrobial Class II
FDA product code LTW covers "Susceptibility Test Cards, Antimicrobial", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LTW
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K852613 | microtech medical systems | MIC-CONCEPT SYSTEM | September 20, 1985 |
| K853273 | austin biological laboratories | PRECEPT CEFTRIAXONE | September 16, 1985 |
| K853772 | austin biological laboratories | PRECEPT METHICILLIN | September 16, 1985 |
| K853685 | austin biological laboratories | PRECEPT TM CARBENICILLIN | September 16, 1985 |
| K853596 | austin biological laboratories | PRECEPT CEFOPERAZONE | September 16, 1985 |
| K853684 | austin biological laboratories | PRECEPT KANAMYCIN | September 13, 1985 |
| K853688 | austin biological laboratories | PRECEPT TM TOBRAMYCIN | September 13, 1985 |
| K853689 | austin biological laboratories | PRECEPT TM MOXALACTAM | September 13, 1985 |
| K853687 | austin biological laboratories | PRECEPT NETILMICIN 32-13 | September 13, 1985 |
| K853686 | austin biological laboratories | PRECEPT TM AMIKACIN | September 13, 1985 |
| K853053 | austin biological laboratories | PRECEPT ERYTHROMYCIN | August 29, 1985 |
| K853263 | austin biological laboratories | PRECEPT AVGMENTIN | August 29, 1985 |
| K850347 | analytical products | API UNISCEPT KB | March 26, 1985 |
| K844159 | analytical products | API UNISCEPT MIC 100UL | December 14, 1984 |
| K844231 | bd becton dickinson vacutainer systems preanalytic | SCEPTOR BETA-LACTAM PLUS MIC PANEL | November 7, 1984 |
| K843733 | analytical products | API UNISCEPT KB | October 24, 1984 |