FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BD FACS SAMPLE PREP ASSISTANT III
K Number: K131301
·
Decision Aug 2, 2013
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
2
Applicant Total
190
Review Days
87
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Basic Information
- Device Name
- BD FACS SAMPLE PREP ASSISTANT III
- K Number
- K131301
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- May 7, 2013
- Decision Date
- August 2, 2013
- Product Code
- PER
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PER), ordered by most recent decision date.
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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