FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MSI-DIFF PLUS
K Number: K880270
·
Decision Mar 1, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
40
Review Days
40
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MSI-DIFF PLUS
- K Number
- K880270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties, Inc.
- Date Received
- January 21, 1988
- Decision Date
- March 1, 1988
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPK), ordered by most recent decision date.
XN CHECK BF
FDA 510(k)
FDA Class 2
·Hematology
XN-L CHECK
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK
FDA 510(k)
FDA Class 2
·Hematology
BC-5D Hematology Control
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK BF
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Medical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946201 | STAND, INFUSION | Apr 18, 1995 | Substantially Equivalent |
| K931947 | CHECKPOINT | Jun 18, 1993 | Substantially Equivalent |
| K926095 | REFRACTROL-SP | Jan 26, 1993 | Substantially Equivalent |
| K924926 | MSI-HCT | Jan 7, 1993 | Substantially Equivalent |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 9, 1990 | Substantially Equivalent |
| K883703 | MSI-CAL 7 | Nov 22, 1988 | Substantially Equivalent |
| K883851 | MSI-CAL 8 | Nov 22, 1988 | Substantially Equivalent |
| K883850 | MSI-CAL 16 | Nov 22, 1988 | Substantially Equivalent |
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent |
| K872140 | (MSI) PATH-SAVER | Jun 15, 1987 | Substantially Equivalent |