FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18
K Number: K851154
·
Decision May 13, 1985
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
17
Applicant Total
4
Review Days
52
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
- ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18
- K Number
- K851154
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2400
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Astral Medical Systems
- Date Received
- March 22, 1985
- Decision Date
- May 13, 1985
- Product Code
- JQT
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQT), ordered by most recent decision date.
ASIMANAGER - AT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ISOSCAN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 795 FLUOROMETER/DENSITOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TARGET READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECTROPHORESIS DATA CENTER (EDC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ICON READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry