FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys BRAHMS PCT
K Number: K173927
·
Decision Jul 6, 2018
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
7
Applicant Total
158
Review Days
192
Basic Information
- Device Name
- Elecsys BRAHMS PCT
- K Number
- K173927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- December 26, 2017
- Decision Date
- July 6, 2018
- Product Code
- PRI
- 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 |
|---|---|---|---|
| PRI | Procalcitonin Assay | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PRI), ordered by most recent decision date.
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