FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIEWER, FLUOROMETIC, MODEL 721
K Number: K770662
·
Decision Apr 15, 1977
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
111
Review Days
8
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Basic Information
- Device Name
- VIEWER, FLUOROMETIC, MODEL 721
- K Number
- K770662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- April 7, 1977
- Decision Date
- April 15, 1977
- Product Code
- JZT
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
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|---|---|---|---|
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| K863789 | CORNING ELISA PLATES | Oct 3, 1986 | Substantially Equivalent |
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| K851939 | CORNING CERTAIN -ISE | Jun 14, 1985 | Substantially Equivalent |
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| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Mar 25, 1985 | Substantially Equivalent |
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