Dried Gram-Positive Mic/Combo Panels
FDA 510(k) K003619 · Dade Microscan, Inc.
510(k) numberK003619
Submission
- Device name
- Dried Gram-Positive Mic/Combo Panels
- Applicant
- Dade Microscan, Inc.
West Sacramento, CA, US - Received
- November 22, 2000
- Decision date
- January 9, 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 |
|---|---|---|
| K043589 | Microscan Dried Gram-Positive Mic/Combo Panels - ErtapenemJWY · Traditional | 02/14/2005SE |
| K023202 | Microscan Synergies PlusJWY · Special | 10/23/2002SE |
| K021184 | Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinLTT · Traditional | 06/20/2002SE |
| K021181 | Microscan Microstrep Plus Panel New Anticrobial-ClarithromycinJWY · Traditional | 06/17/2002SE |
| K021018 | Microscan Microstrep Plus Panel - ChloramphenicolJWY · Traditional | 06/11/2002SE |
| K021188 | Microscan Microstrep Plus Panel New Antimicrobial-CefepimeJWY · Traditional | 06/06/2002SE |
| K021169 | Microstrep Plus Panel, AzithromycinJWY · Traditional | 06/06/2002SE |
| K021111 | Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeLTT · Traditional | 06/06/2002SE |
| K021110 | Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneJWY · Traditional | 06/06/2002SE |
| K021078 | Microscan Microstrep Plus Panel New Antimicrobial-ErythromycinLTT · Traditional | 06/06/2002SE |
Questions and answers
When was Dried Gram-Positive Mic/Combo Panels cleared by the FDA?
Dried Gram-Positive Mic/Combo Panels (K003619) received a 510(k) decision of Substantially Equivalent on January 9, 2001, 48 days after the submission was received.
What is the product code of K003619?
The FDA product code is LTT – Panels, Test, Susceptibility, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.