510(k) K822329
- Device
- Antituberculous Drugs (sire)
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K822329
- Product code
- JTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-02
- Date received
- 1982-08-03
- Regulation
- 866.1640
- Classification name
- Susceptibility Test Powders, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1119779
- 2647876
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTT#
| 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 |
| K820578 | MEZLIN DIAGNOSTIC REAGENT | Miles Pharmaceuticals | 1982-05-12 |