FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY ANALYZER
K Number: K823344
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
28
Review Days
50
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Basic Information
- Device Name
- HEMATOLOGY ANALYZER
- K Number
- K823344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Diagnostics
- Date Received
- November 8, 1982
- Decision Date
- December 28, 1982
- Product Code
- GKL
- 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
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|---|---|---|---|
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| K961439 | ABBOTT CELL-DYN 4000 SYSTEM | Oct 18, 1996 | Substantially Equivalent |
| K890491 | CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER | Apr 18, 1989 | Substantially Equivalent |
| K881242 | CELL-DYN RAPID-LYSE AND HEMOGLOBLIN | Apr 21, 1988 | Substantially Equivalent |
| K881130 | CELL-DYN ISOTONIC DILUENT | Mar 31, 1988 | Substantially Equivalent |
| K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | Sep 9, 1987 | Substantially Equivalent |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | Sep 9, 1987 | Substantially Equivalent |
| K873408 | MODEL 690 SPECTROPHOTOMETER | Sep 8, 1987 | Substantially Equivalent |
| K872761 | CELL-DYN 610 HEMATOLOGY ANALYZER | Aug 6, 1987 | Substantially Equivalent |