FDA 510(k)
Substantially Equivalent
🇺🇸 United States
UNI-PLATE
K Number: K852643
·
Decision Aug 8, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
48
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
- UNI-PLATE
- K Number
- K852643
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties Laboratories
- Date Received
- June 21, 1985
- Decision Date
- August 8, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- HE
- Third Party
- N
Other Clearances by Medical Specialties Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K844897 | HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 | Mar 22, 1985 | Substantially Equivalent |
| K840114 | COAGULATION FACTOR DEFICIENT PLASMA | Feb 4, 1984 | Substantially Equivalent |
| K823587 | UNI-CELL | Jan 5, 1983 | Substantially Equivalent |
| K810268 | NORMLCERA | Mar 6, 1981 | Substantially Equivalent |