Pasco Mic and Mic/Id Panels
FDA 510(k) K982235 · Pasco Laboratories, Inc.
510(k) numberK982235
Submission
- Device name
- Pasco Mic and Mic/Id Panels
- Applicant
- Pasco Laboratories, Inc.
Wheat Ridge, CO, US - Received
- June 25, 1998
- Decision date
- July 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1620
- Specialty
- Microbiology
Other 510(k)s with product code JTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | Hardy Diagnostics | 08/20/2026SE |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
| K261853 | Gepotidacin GEP 10 µgJTN · Traditional | Liofilchem, Inc. | 07/23/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 05/11/2026SE |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 12/05/2025SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | Hardy Diagnostics | 11/20/2025SE |
| K251879 | Sulopenem SPM 2 µgJTN · Traditional | Liofilchem | 08/12/2025SE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 06/26/2025SE |
| K250885 | Ceftobiprole BPR 5 µg DiscJTN · Traditional | Liofilchem, Inc. | 06/23/2025SE |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 06/12/2025SE |
More from Thermo Fisher Scientific (Oxoid Ltd.)
| 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 (K982235) received a 510(k) decision of Substantially Equivalent on July 30, 1998, 35 days after the submission was received.
What is the product code of K982235?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.