FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS BRAHMS PCT Reagent Pack and Calibrators
K Number: K200236
·
Decision Feb 25, 2020
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
4
Applicant Total
16
Review Days
26
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Basic Information
- Device Name
- VITROS BRAHMS PCT Reagent Pack and Calibrators
- K Number
- K200236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Clinical Diagnostics
- Date Received
- January 30, 2020
- Decision Date
- February 25, 2020
- Product Code
- PMT
- 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 |
|---|---|---|---|
| PMT | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PMT), ordered by most recent decision date.
Atellica IM BRAHMS Procalcitonin (PCT)
FDA 510(k)
FDA Class 2
·Microbiology
VIDAS B.R.A.H.M.S. PCT (PCT)
FDA 510(k)
FDA Class 2
·Microbiology
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
FDA 510(k)
FDA Class 2
·Microbiology
B.R.A.H.M.S PCT sensitive KRYPTOR
FDA 510(k)
FDA Class 2
·Microbiology
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| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Aug 23, 2023 | Substantially Equivalent |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Aug 9, 2023 | Substantially Equivalent |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Dec 12, 2022 | Substantially Equivalent |
| K213626 | VITROS AFP | Jun 15, 2022 | Substantially Equivalent |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Jan 28, 2022 | Substantially Equivalent |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Oct 4, 2021 | Substantially Equivalent |
| K163433 | VITROS Chemistry Products GLU Slides | Sep 18, 2017 | Substantially Equivalent |