FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOMATED SLIDE SPINNER
K Number: K771898
·
Decision Oct 18, 1977
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
6
Review Days
12
Basic Information
- Device Name
- AUTOMATED SLIDE SPINNER
- K Number
- K771898
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.5850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- DYNATECH CRYOMEDICAL CO.
- Date Received
- October 6, 1977
- Decision Date
- October 18, 1977
- Product Code
- GKJ
- 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 |
|---|---|---|---|
| GKJ | Spinner, Slide, Automated | FDA class 1 | Hematology |
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Other Clearances by DYNATECH CRYOMEDICAL CO.
| K Number | Device Name | ||
|---|---|---|---|
| K771815 | SIGMOSCOPE | Oct 7, 1977 | Substantially Equivalent |
| K770896 | COLPOSCOPE MODEL II | Jun 3, 1977 | Substantially Equivalent |
| K770614 | MONITOR, GAS MANIFOLD | Apr 7, 1977 | Substantially Equivalent |
| K761205 | DYNATECH JD7/JD7P COLPOSCOPE | Dec 17, 1976 | Substantially Equivalent |
| K760763 | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I | Oct 20, 1976 | Substantially Equivalent |