FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SYRINGE FILTERS
K Number: K840556
·
Decision Mar 5, 1984
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
4
Applicant Total
111
Review Days
26
Basic Information
- Device Name
- DISPOSABLE SYRINGE FILTERS
- K Number
- K840556
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- CORNING MEDICAL & SCIENTIFIC
- Date Received
- February 8, 1984
- Decision Date
- March 5, 1984
- Product Code
- KET
- 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 |
|---|---|---|---|
| KET | Filters, Cell Collection, Tissue Processing | FDA class 1 | Pathology |
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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 |
| K853634 | CORNING CELL WELLS-MULTIPLE WELL PLATES | Sep 16, 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 |