Pasco Mic and Mic/Id Panels
FDA 510(k) K935805 · Pasco Laboratories, Inc.
510(k) numberK935805
Submission
- Device name
- Pasco Mic and Mic/Id Panels
- Applicant
- Pasco Laboratories, Inc.
Wheat Ridge, CO, US - Received
- December 2, 1993
- Decision date
- June 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | Accumed Intl., Inc. | 12/17/1998SE |
| 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 |
|---|---|---|
| K042331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 10/07/2004SE |
| K041776 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 08/03/2004SE |
| K041214 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/07/2004SE |
| K033119 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 11/18/2003SE |
| K031727 | Pasco Mic and Mic/Id Panels, GemifloxacinJWY · Traditional | 07/30/2003SE |
| K031205 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/13/2003SE |
| K031103 | Pasco Mic and Mic/Id Panels (Ertapenem)JWY · Traditional | 06/12/2003SE |
| K030933 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 05/01/2003SE |
| K030620 | Pasco Mic and Mic/Id PanelsLTT · Traditional | 04/14/2003SE |
| K020331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 03/20/2002SE |
Questions and answers
When was Pasco Mic and Mic/Id Panels cleared by the FDA?
Pasco Mic and Mic/Id Panels (K935805) received a 510(k) decision of Substantially Equivalent on June 13, 1994, 193 days after the submission was received.
What is the product code of K935805?
The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.