FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROSCOPE STAGE HEATER
K Number: K881467
·
Decision Apr 18, 1988
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
6
Review Days
12
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Basic Information
- Device Name
- MICROSCOPE STAGE HEATER
- K Number
- K881467
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Cryodyne Technologies, Inc.
- Date Received
- April 6, 1988
- Decision Date
- April 18, 1988
- Product Code
- KEJ
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| KEJ | Stages, Microscope | FDA class 1 | Pathology |
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 |
| K881465 | CRYOBIOLOGICAL FREEZER | Apr 21, 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 |