FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K Number: K873348
·
Decision Sep 9, 1987
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
28
Review Days
20
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Basic Information
- Device Name
- CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
- K Number
- K873348
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Diagnostics
- Date Received
- August 20, 1987
- Decision Date
- September 9, 1987
- Product Code
- GGK
- 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | 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 |
| 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 |
| K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER | Mar 17, 1987 | Substantially Equivalent |