FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM

K Number: K851945 · Decision May 24, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
14
Applicant Total
86
Review Days
21

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Basic Information

Device Name
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM
K Number
K851945
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
May 3, 1985
Decision Date
May 24, 1985
Product Code
KZR
Advisory Committee
Clinical Chemistry
Review Advisory Committee
CH
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KZR Chromatography (Liquid, Gel), Clinical Use

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K980601 VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
K955844 APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K955774 VARIS PORTALVISION
K954467 CADPLAN BT
K943224 VARIAN MULTILEAF COLLIMATOR
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