FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KVM ISOTONIC FLUSH SOLUTION
K Number: K883989
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
37
Applicant Total
5
Review Days
22
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Basic Information
- Device Name
- KVM ISOTONIC FLUSH SOLUTION
- K Number
- K883989
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Kvm Technologies, Inc.
- Date Received
- September 20, 1988
- Decision Date
- October 12, 1988
- Product Code
- GIF
- 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIF), ordered by most recent decision date.
KVM ISOTONIC DILUENT
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HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
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SYSMEX QUICKLYSER-II (QLS-200A)
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CELL-DYN ISOTONIC DILUENT
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CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
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FDA Class 1
·Hematology
OSMOCEL 3
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Kvm Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925666 | THERAPACER 3000 | Mar 9, 1993 | Substantially Equivalent |
| K883990 | KVM ISOTONIC DILUENT | Oct 12, 1988 | Substantially Equivalent |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Oct 12, 1988 | Substantially Equivalent |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | Oct 12, 1988 | Substantially Equivalent |