Product code JTT
- Device name
- Susceptibility Test Powders, Antimicrobial
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1640
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N50407 | STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE | The Upjohn Co. | 1971-06-30 |
| N50413 | GEOPEN SUSCEPTIBILITY POWDER | Pfizer, Inc. | 1970-09-10 |
| N50163 | STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) | The Upjohn Co. | 1970-07-29 |
| N50042 | POTASSIUM PENICILLIN G DIAG SYS POWDER | Pfizer, Inc. | 1970-02-27 |
| N50009 | TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER | Pfizer, Inc. | 1970-02-27 |
| N50062 | OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER | Pfizer, Inc. | 1969-11-24 |
| N50036 | STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW | Pfizer, Inc. | 1969-11-24 |
| N50016 | BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER | Pfizer, Inc. | 1969-11-24 |
| N50100 | VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN | Pfizer, Inc. | 1969-09-04 |
| N61034 | LINCOCIN SUSCEPTIBILITY PWD | The Upjohn Co. | 1968-10-09 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983310 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN | Accumed Intl., Inc. | 1998-12-17 |
| K935805 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 1994-06-13 |
| K895362 | BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-12-01 |
| K880574 | MODIFIED IMIPENEM SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | 1988-05-04 |
| K872081 | CIPRO (TM) DIAGNOSTIC POWDER | Miles Pharmaceuticals | 1987-06-15 |
| K864442 | NORFLOXACIN SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | 1986-12-11 |
| K855071 | IMIPENEM SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | 1986-03-06 |
| K855106 | IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-03-06 |
| K855207 | IMIPENEM 10 MCG SENSITIVITY DISCS | Difco Laboratories, Inc. | 1986-03-06 |
| K860031 | GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK | Organon Teknika Corp. | 1986-03-06 |
| K830758 | AZLIN AZLOCILIN SODIUM-DIAG. REAGENT | Miles Laboratories, Inc. | 1983-05-25 |
| K822866 | MOXALACTAM | Lilly Research Laboratories | 1982-12-28 |
| K822329 | ANTITUBERCULOUS DRUGS (SIRE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-02 |
| K820578 | MEZLIN DIAGNOSTIC REAGENT | Miles Pharmaceuticals | 1982-05-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30382902316450 | BD BBL™ Sensi-Disc™ Imipenem 10 µg | BECTON, DICKINSON AND COMPANY | 2016-05-03 |
| 00382902316442 | BD BBL™ Sensi-Disc™ Imipenem 10 µg | BECTON, DICKINSON AND COMPANY | 2016-05-03 |