FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K170652
·
Decision Jun 1, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
7
Applicant Total
16
Review Days
90
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Basic Information
- Device Name
- 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
- K Number
- K170652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher Diagnostics
- Date Received
- March 3, 2017
- Decision Date
- June 1, 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.
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
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LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
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Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
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B R A H M S PCT sensitive KRYPTOR
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Other Clearances by Fisher Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Sep 13, 2007 | Substantially Equivalent |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Jul 18, 2006 | Substantially Equivalent |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | May 10, 2006 | Substantially Equivalent |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | Jan 24, 2005 | Substantially Equivalent |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | Aug 12, 2004 | Substantially Equivalent |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | Jul 21, 2004 | Substantially Equivalent |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | Dec 9, 2002 | Substantially Equivalent |
| K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | Feb 15, 2002 | Substantially Equivalent |
| K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | Sep 7, 2001 | Substantially Equivalent |
| K850160 | FISHER DIAGNOSTICS LATEST-CRP TEST KIT | Apr 19, 1985 | Substantially Equivalent |