JTT · Susceptibility Test Powders, Antimicrobial
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | JTT |
|---|---|
| Device Name | Susceptibility Test Powders, 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 (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983310 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN | Accumed Intl., Inc. | Dec 17, 1998 | SESE |
| K935805 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | Jun 13, 1994 | SESE |
| K895362 | BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 1, 1989 | SESE |
| K880574 | MODIFIED IMIPENEM SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | May 4, 1988 | SESE |
| K872081 | CIPRO (TM) DIAGNOSTIC POWDER | Miles Pharmaceuticals | Jun 15, 1987 | SESE |
| K864442 | NORFLOXACIN SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | Dec 11, 1986 | SESE |
| K860031 | GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK | Organon Teknika Corp. | Mar 6, 1986 | SESE |
| K855207 | IMIPENEM 10 MCG SENSITIVITY DISCS | Difco Laboratories, Inc. | Mar 6, 1986 | SESE |
| K855106 | IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 6, 1986 | SESE |
| K855071 | IMIPENEM SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | Mar 6, 1986 | SESE |
| K830758 | AZLIN AZLOCILIN SODIUM-DIAG. REAGENT | Miles Laboratories, Inc. | May 25, 1983 | SESE |
| K822866 | MOXALACTAM | Lilly Research Laboratories | Dec 28, 1982 | SESE |
| K822329 | ANTITUBERCULOUS DRUGS (SIRE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 2, 1982 | SESE |
| K820578 | MEZLIN DIAGNOSTIC REAGENT | Miles Pharmaceuticals | May 12, 1982 | SESE |
| N50407 | STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE | The Upjohn Co. | Jun 30, 1971 | APRL |
| N50413 | GEOPEN SUSCEPTIBILITY POWDER | Pfizer, Inc. | Sep 10, 1970 | APRL |
| N50163 | STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) | The Upjohn Co. | Jul 29, 1970 | APRL |
| N50042 | POTASSIUM PENICILLIN G DIAG SYS POWDER | Pfizer, Inc. | Feb 27, 1970 | APRL |
| N50009 | TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER | Pfizer, Inc. | Feb 27, 1970 | APRL |
| N50062 | OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER | Pfizer, Inc. | Nov 24, 1969 | APRL |
Top Applicants
- Pfizer, Inc. — 7 clearances
- The Upjohn Co. — 3 clearances
- Merck, Sharp & Dohme — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- Miles Pharmaceuticals — 2 clearances
