FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE STERILE FILTER SYSTEM
K Number: K831450
·
Decision Jun 2, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
111
Review Days
28
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Basic Information
- Device Name
- DISPOSABLE STERILE FILTER SYSTEM
- K Number
- K831450
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- May 5, 1983
- Decision Date
- June 2, 1983
- Product Code
- LIB
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | FDA class 1 | Microbiology |
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Other Clearances by Corning Medical & Scientific
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |