LTW · Susceptibility Test Cards, Antimicrobial
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | LTW |
|---|---|
| Device Name | Susceptibility Test Cards, Antimicrobial |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852613 | MIC-CONCEPT SYSTEM | Microtech Medical Systems, Inc. | Sep 20, 1985 | SESE |
| K853772 | PRECEPT METHICILLIN | Austin Biological Laboratories | Sep 16, 1985 | SESE |
| K853685 | PRECEPT TM CARBENICILLIN | Austin Biological Laboratories | Sep 16, 1985 | SESE |
| K853596 | PRECEPT CEFOPERAZONE | Austin Biological Laboratories | Sep 16, 1985 | SESE |
| K853273 | PRECEPT CEFTRIAXONE | Austin Biological Laboratories | Sep 16, 1985 | SESE |
| K853689 | PRECEPT TM MOXALACTAM | Austin Biological Laboratories | Sep 13, 1985 | SESE |
| K853688 | PRECEPT TM TOBRAMYCIN | Austin Biological Laboratories | Sep 13, 1985 | SESE |
| K853687 | PRECEPT NETILMICIN 32-13 | Austin Biological Laboratories | Sep 13, 1985 | SESE |
| K853686 | PRECEPT TM AMIKACIN | Austin Biological Laboratories | Sep 13, 1985 | SESE |
| K853684 | PRECEPT KANAMYCIN | Austin Biological Laboratories | Sep 13, 1985 | SESE |
| K853263 | PRECEPT AVGMENTIN | Austin Biological Laboratories | Aug 29, 1985 | SESE |
| K853053 | PRECEPT ERYTHROMYCIN | Austin Biological Laboratories | Aug 29, 1985 | SESE |
| K850347 | API UNISCEPT KB | Analytical Products, Inc. | Mar 26, 1985 | SESE |
| K844159 | API UNISCEPT MIC 100UL | Analytical Products, Inc. | Dec 14, 1984 | SESE |
| K844231 | SCEPTOR BETA-LACTAM PLUS MIC PANEL | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 7, 1984 | SESE |
| K843733 | API UNISCEPT KB | Analytical Products, Inc. | Oct 24, 1984 | SESE |
| N50510 | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD | Biomerieux Vitek, Inc. | Mar 2, 1978 | APRL |
Top Applicants
- Austin Biological Laboratories — 11 clearances
- Analytical Products, Inc. — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Microtech Medical Systems, Inc. — 1 clearance
