FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACT/ALERT MP Reagent System
K Number: K190405
·
Decision May 15, 2019
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
251
Review Days
85
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Basic Information
- Device Name
- BACT/ALERT MP Reagent System
- K Number
- K190405
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- February 19, 2019
- Decision Date
- May 15, 2019
- Product Code
- MDB
- 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
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