FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRYOBIOLOGICAL FREEZER
K Number: K881465
·
Decision Apr 21, 1988
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
0
Applicant Total
6
Review Days
15
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Basic Information
- Device Name
- CRYOBIOLOGICAL FREEZER
- K Number
- K881465
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9225
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cryodyne Technologies, Inc.
- Date Received
- April 6, 1988
- Decision Date
- April 21, 1988
- Product Code
- KSP
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KSP | Apparatus, Cell-Freezing And Reagents | FDA class 1 | Hematology |
Other Clearances by Cryodyne Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926464 | L.C.S.3000 | Aug 24, 1993 | Substantially Equivalent |
| K932520 | CALIBRATION GAS | Aug 19, 1993 | Substantially Equivalent |
| K881467 | MICROSCOPE STAGE HEATER | Apr 18, 1988 | Substantially Equivalent |
| K881466 | CELL-CULTURE SHAKER | Apr 18, 1988 | Substantially Equivalent |
| K860738 | CTC 30, 40, 1 LIQUID OXYGEN LITERS | Aug 6, 1986 | Substantially Equivalent |