FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MSI-HCT
K Number: K924926
·
Decision Jan 7, 1993
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
6
Applicant Total
40
Review Days
99
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Basic Information
- Device Name
- MSI-HCT
- K Number
- K924926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Specialties, Inc.
- Date Received
- September 30, 1992
- Decision Date
- January 7, 1993
- Product Code
- GLK
- 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 |
|---|---|---|---|
| GLK | Control, Hematocrit | FDA class 2 | Hematology |
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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 |
| 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 |
| K880270 | MSI-DIFF PLUS | Mar 1, 1988 | Substantially Equivalent |
| K872140 | (MSI) PATH-SAVER | Jun 15, 1987 | Substantially Equivalent |