FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
K Number: K172713
·
Decision Dec 10, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
7
Applicant Total
45
Review Days
93
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Basic Information
- Device Name
- Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
- K Number
- K172713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- September 8, 2017
- Decision Date
- December 10, 2017
- 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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ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
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·Microbiology
B R A H M S PCT sensitive KRYPTOR
FDA 510(k)
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