FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
K Number: K243804
·
Decision Aug 20, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
49
Applicant Total
270
Review Days
252
Basic Information
- Device Name
- MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- K Number
- K243804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- December 11, 2024
- Decision Date
- August 20, 2025
- Product Code
- LTT
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LTT | Panels, Test, Susceptibility, Antimicrobial | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K252580 | iQ200 Series | Sep 10, 2025 | Substantially Equivalent |
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| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Aug 15, 2025 | Substantially Equivalent |
| K243483 | Access hsTnI | Aug 1, 2025 | Substantially Equivalent |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Jul 18, 2025 | Substantially Equivalent |