FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORNING CELL WELLS-MULTIPLE WELL PLATES
K Number: K853634
·
Decision Sep 16, 1985
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
7
Applicant Total
111
Review Days
17
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
- CORNING CELL WELLS-MULTIPLE WELL PLATES
- K Number
- K853634
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- August 30, 1985
- Decision Date
- September 16, 1985
- Product Code
- KIZ
- 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 |
|---|---|---|---|
| KIZ | Dish, Tissue Culture | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIZ), ordered by most recent decision date.
MULTIWELL CULTURE PLATE INSERTS
FDA 510(k)
FDA Class 1
·Hematology
TISSUE CULTURE DISHES
FDA 510(k)
FDA Class 1
·Hematology
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES
FDA 510(k)
FDA Class 1
·Hematology
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE
FDA 510(k)
FDA Class 1
·Hematology
REMOVAWELL TISSUE CULTURE PLATE W/LID
FDA 510(k)
FDA Class 1
·Hematology
120 WELL HISTO-PLATE
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Corning Medical & Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Jan 12, 1988 | Substantially Equivalent |
| K872273 | CORNING EASY WASH ELISA PLATES | Jul 7, 1987 | Substantially Equivalent |
| K872076 | CORNING DISPOSABLE ROLLER BOTTLES | Jun 15, 1987 | Substantially Equivalent |
| K863789 | CORNING ELISA PLATES | Oct 3, 1986 | Substantially Equivalent |
| K854024 | CORNING MAGIC MAB HCG RADIOIMMUNOASSAY | Nov 26, 1985 | Substantially Equivalent |
| K851939 | CORNING CERTAIN -ISE | Jun 14, 1985 | Substantially Equivalent |
| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | Jun 13, 1985 | Substantially Equivalent |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Mar 25, 1985 | Substantially Equivalent |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Mar 12, 1985 | Substantially Equivalent |
| K844671 | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | Feb 25, 1985 | Substantially Equivalent |