FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARANTROL
K Number: K780835
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
1
Review Days
30
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
- ARANTROL
- K Number
- K780835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Aranco Diagnostic Laboratories, Inc.
- Date Received
- May 23, 1978
- Decision Date
- June 22, 1978
- 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