Pasco Mic and Mic/Id Panels
FDA 510(k) K010508 · Pasco Laboratories, Inc.
510(k) numberK010508
Submission
- Device name
- Pasco Mic and Mic/Id Panels
- Applicant
- Pasco Laboratories, Inc.
Wheat Ridge, CO, US - Received
- February 21, 2001
- Decision date
- April 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | Beckman Coulter, Inc. | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 08/15/2025SE |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 07/18/2025SE |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )LTT · Traditional | Beckman Coulter, Inc. | 11/16/2020SE |
| K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)LTT · Special | Beckman Coulter, Inc. | 06/29/2020SE |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/18/2020SE |
| K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/03/2020SE |
| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam…LTT · Traditional | Beckman Coulter, Inc. | 02/12/2019SE |
| K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…LTT · Traditional | Beckman Coulter, Inc. | 12/15/2017SE |
| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 12/07/2017SE |
More from Beckman Coulter, 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 (K010508) received a 510(k) decision of Substantially Equivalent on April 23, 2001, 61 days after the submission was received.
What is the product code of K010508?
The FDA product code is LTT – Panels, Test, Susceptibility, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.