FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KVM PREPACK HEMATOLOGY REAGENT SET
K Number: K883992
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
5
Review Days
22
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
- KVM PREPACK HEMATOLOGY REAGENT SET
- K Number
- K883992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Kvm Technologies, Inc.
- Date Received
- September 20, 1988
- Decision Date
- October 12, 1988
- Product Code
- GKK
- 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 |
|---|---|---|---|
| GKK | Cyanomethemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKK), ordered by most recent decision date.
RAICHEM TM HEMOGLOBIN REAGENT
FDA 510(k)
FDA Class 2
·Hematology
MODIFIED HEMOGLOBIN REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
HEMOGLOBIN REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
CYMET-PLUS
FDA 510(k)
FDA Class 2
·Hematology
UNIPAK HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
HEMOTOLOGY PRODU&TS (5 IN ALL)
FDA 510(k)
FDA Class 2
·Hematology