FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
K Number: K162297
·
Decision Apr 18, 2017
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
41
Review Days
245
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Basic Information
- Device Name
- Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- K Number
- K162297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories
- Date Received
- August 16, 2016
- Decision Date
- April 18, 2017
- Product Code
- PTF
- 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 |
|---|---|---|---|
| PTF | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PTF), ordered by most recent decision date.
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
FDA 510(k)
FDA Class 2
·Microbiology
Access PCT
FDA 510(k)
FDA Class 2
·Microbiology
Access PCT, Access PCT Calibrators
FDA 510(k)
FDA Class 2
·Microbiology
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