FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 5000, LIQUID CHROMATOGRAPHY
K Number: K781379
·
Decision Sep 14, 1978
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
24
Applicant Total
86
Review Days
34
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
- MODEL 5000, LIQUID CHROMATOGRAPHY
- K Number
- K781379
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Varian Assoc., Inc.
- Date Received
- August 11, 1978
- Decision Date
- September 14, 1978
- Product Code
- KIE
- 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 |
|---|---|---|---|
| KIE | Apparatus, High Pressure Liquid Chromatography | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIE), ordered by most recent decision date.
WATERS 515 HPLC PUMP (515)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WATERS(TM) 996 PDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHROMATOGRAPHY CLINICAL USE 75JQR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EQUIPMENT/MATERIAL DECONTAMINATING KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Varian Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000922 | PROTON VISION | May 24, 2000 | Substantially Equivalent |
| K992762 | BRACHYVISION 6.0 | Mar 9, 2000 | Substantially Equivalent |
| K992751 | SOMAVISION | Feb 16, 2000 | Substantially Equivalent |
| K992753 | CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM | Sep 3, 1999 | Substantially Equivalent |
| K990085 | MILLENNIUM MLC -120 | Feb 8, 1999 | Substantially Equivalent |
| 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 |