FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K Number: K210287
·
Decision Oct 28, 2021
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
288
Applicant Total
251
Review Days
268
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Basic Information
- Device Name
- VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
- K Number
- K210287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- February 2, 2021
- Decision Date
- October 28, 2021
- Product Code
- LON
- 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 |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | FDA class 2 | Microbiology |
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Other Clearances by bioMerieux, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | Apr 15, 2026 | Substantially Equivalent |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | Aug 21, 2025 | Substantially Equivalent |
| K234012 | VITEK COMPACT PRO | Mar 14, 2025 | Substantially Equivalent |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | Jun 12, 2024 | Substantially Equivalent |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | Jun 7, 2024 | Substantially Equivalent |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | May 1, 2024 | Substantially Equivalent |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | Mar 11, 2024 | Substantially Equivalent |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | Oct 23, 2023 | Substantially Equivalent |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | Jul 5, 2023 | Substantially Equivalent |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | Jun 26, 2023 | Substantially Equivalent |