FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTROFLUOROMETER SF-330
K Number: K780362
·
Decision Mar 22, 1978
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
86
Review Days
16
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Basic Information
- Device Name
- SPECTROFLUOROMETER SF-330
- K Number
- K780362
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Varian Assoc., Inc.
- Date Received
- March 6, 1978
- Decision Date
- March 22, 1978
- Product Code
- KHO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | Oct 21, 1998 | Substantially Equivalent |
| K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Jul 26, 1996 | Substantially Equivalent |
| K955774 | VARIS PORTALVISION | Mar 15, 1996 | Substantially Equivalent |
| K954467 | CADPLAN BT | Mar 15, 1996 | Substantially Equivalent |
| K943224 | VARIAN MULTILEAF COLLIMATOR | Feb 2, 1996 | Substantially Equivalent |