FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PF4 Enhanced assay
K Number: K201570
·
Decision Sep 11, 2020
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
12
Applicant Total
2
Review Days
92
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Basic Information
- Device Name
- PF4 Enhanced assay
- K Number
- K201570
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7695
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immucor Gti Diagnostics, Inc.
- Date Received
- June 11, 2020
- Decision Date
- September 11, 2020
- Product Code
- LCO
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| LCO | Platelet Factor 4 Radioimmunoassay | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCO), ordered by most recent decision date.
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Other Clearances by Immucor Gti Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201311 | PF4 IgG assay | Jun 18, 2020 | Substantially Equivalent |