Imipenem 10 MCG Sensitivity Discs
FDA 510(k) K855207 · Difco Laboratories, Inc.
510(k) numberK855207
Submission
- Device name
- Imipenem 10 MCG Sensitivity Discs
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- December 30, 1985
- Decision date
- March 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTT – Susceptibility Test Powders, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code JTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | Accumed Intl., Inc. | 12/17/1998SE |
| K935805 | Pasco Mic and Mic/Id PanelsJTT · Traditional | Pasco Laboratories, Inc. | 06/13/1994SE |
| K895362 | Bactec Pyrazinamide Susceptibility TestJTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/01/1989SE |
| K880574 | Modified Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 05/04/1988SE |
| K872081 | Cipro (TM) Diagnostic PowderJTT · Traditional | Miles Pharmaceuticals | 06/15/1987SE |
| K864442 | Norfloxacin Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 12/11/1986SE |
| K860031 | Gen Diagnostics' Imipenem 10 MCG Susceptibity DiskJTT · Traditional | Organon Teknika Corp. | 03/06/1986SE |
| K855106 | Imipenem 10 MCG Sensi-Disc,Cat. # 31644/31645JTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/06/1986SE |
| K855071 | Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 03/06/1986SE |
| K830758 | Azlin Azlocilin Sodium-Diag. ReagentJTT · Traditional | Miles Laboratories, Inc. | 05/25/1983SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971211 | Dispens-O-Disc SparfloxacinJTN · Traditional | 04/14/1997SE |
| K971120 | Dispens-O-Disc (TM) LevofloxacinJTN · Traditional | 04/14/1997SE |
| K963508 | Dispens-O-Disc MeropenemJTN · Traditional | 09/26/1996SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | 04/26/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
| K941016 | Dispens-O-Disc(Tm) NitrocefinJTO · Traditional | 06/30/1994SE |
Questions and answers
When was Imipenem 10 MCG Sensitivity Discs cleared by the FDA?
Imipenem 10 MCG Sensitivity Discs (K855207) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 66 days after the submission was received.
What is the product code of K855207?
The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.