Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin
FDA 510(k) K983310 · Accumed Intl., Inc.
510(k) numberK983310
Submission
- Device name
- Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin
- Applicant
- Accumed Intl., Inc.
Westlake, OH, US - Received
- September 21, 1998
- Decision date
- December 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K855207 | Imipenem 10 MCG Sensitivity DiscsJTT · Traditional | Difco Laboratories, Inc. | 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 |
|---|---|---|
| K984489 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 02/16/1999SE |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with GrepafloxacinLTT · Traditional | 12/18/1998SE |
| K983309 | Sensititre 19 - 24 Hour Susceptibility Plates with LevofloxacinLTT · Traditional | 12/14/1998SE |
| K983301 | Sensititre 18-24 Hour Susceptibility Plates with TrovafloxacinJWY · Traditional | 11/25/1998SE |
| K982786 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 10/16/1998SE |
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | 01/22/1998SE |
| K964689 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 08/18/1997SE |
| K972756 | Modification of Est Culture System II - MycoMDB · Traditional | 08/01/1997SE |
| K965190 | Sensititre Haemophilus/Streptococcus Pneumoniae Mic PlateJWY · Traditional | 03/19/1997SE |
| K960366 | Sensititre 18 Hour Susceptibility PlatesLTT · Traditional | 04/09/1996SE |
Questions and answers
When was Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin cleared by the FDA?
Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin (K983310) received a 510(k) decision of Substantially Equivalent on December 17, 1998, 87 days after the submission was received.
What is the product code of K983310?
The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.