MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
FDA 510(k) K172912 · Beckman Coulter, Inc.
510(k) numberK172912
Submission
- Device name
- MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
- Applicant
- Beckman Coulter, Inc.
West Sacramento, CA, US - Received
- September 25, 2017
- Decision date
- December 7, 2017
- 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
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|---|---|---|---|
| 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 |
| K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 -…LTT · Traditional | Beckman Coulter, Inc. | 12/01/2017SE |
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| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL) cleared by the FDA?
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL) (K172912) received a 510(k) decision of Substantially Equivalent on December 7, 2017, 73 days after the submission was received.
What is the product code of K172912?
The FDA product code is LTT – Panels, Test, Susceptibility, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.