FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NORMLCERA
K Number: K810268
·
Decision Mar 6, 1981
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
44
Applicant Total
5
Review Days
32
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
- NORMLCERA
- K Number
- K810268
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2800
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties Laboratories
- Date Received
- February 2, 1981
- Decision Date
- March 6, 1981
- Product Code
- KIS
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KIS | Sera, Animal And Human | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIS), ordered by most recent decision date.
ANIMAL AND HUMAN SERA
FDA 510(k)
FDA Class 1
·Hematology
BOVINE CALF SERUM SUPPLEMENTED #A-2159
FDA 510(k)
FDA Class 1
·Hematology
BOVINE CALF SERUM CATALOG #A-2119
FDA 510(k)
FDA Class 1
·Hematology
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
FDA 510(k)
FDA Class 1
·Hematology
MLC NORMAL SERUM
FDA 510(k)
FDA Class 1
·Hematology
FETAL BOVINE SERUM
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Medical Specialties Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K852643 | UNI-PLATE | Aug 8, 1985 | Substantially Equivalent |
| 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 |