FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDATRON CUVETTE DISC
K Number: K873656
·
Decision Dec 14, 1987
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
1
Review Days
95
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
- MEDATRON CUVETTE DISC
- K Number
- K873656
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medatron, Inc.
- Date Received
- September 10, 1987
- Decision Date
- December 14, 1987
- Product Code
- JRI
- 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 |
|---|---|---|---|
| JRI | Cuvette, Thermostated | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRI), ordered by most recent decision date.
THERMO SET ELECTRONIC TEM. CONTROLLER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TEMPERATURE REGULATED FIVE CELL HOLDERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCUVETTE II
FDA 510(k)
FDA Class 1
·Clinical Chemistry