FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELL-CULTURE SHAKER
K Number: K881466
·
Decision Apr 18, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
6
Review Days
12
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CELL-CULTURE SHAKER
- K Number
- K881466
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cryodyne Technologies, Inc.
- Date Received
- April 6, 1988
- Decision Date
- April 18, 1988
- Product Code
- KJB
- 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 |
|---|---|---|---|
| KJB | Apparatus, Roller | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KJB), ordered by most recent decision date.
CORNING DISPOSABLE ROLLER BOTTLES
FDA 510(k)
FDA Class 1
·Hematology
BIOGLAS MICROCARRIER BEAD
FDA 510(k)
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 |
| K881465 | CRYOBIOLOGICAL FREEZER | Apr 21, 1988 | Substantially Equivalent |
| K881467 | MICROSCOPE STAGE HEATER | Apr 18, 1988 | Substantially Equivalent |
| K860738 | CTC 30, 40, 1 LIQUID OXYGEN LITERS | Aug 6, 1986 | Substantially Equivalent |