FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNI-CELL
K Number: K823587
·
Decision Jan 5, 1983
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
9
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- UNI-CELL
- K Number
- K823587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties Laboratories
- Date Received
- December 6, 1982
- Decision Date
- January 5, 1983
- Product Code
- GLQ
- 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 |
|---|---|---|---|
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | FDA class 2 | Hematology |
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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 |
| K810268 | NORMLCERA | Mar 6, 1981 | Substantially Equivalent |