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510(k) K802725

VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS by Varian Assoc., Inc. — Product Code KZR

K802725 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), a Class I device regulated under 21 CFR 862.2260. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
October 31, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography (Liquid, Gel), Clinical Use
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type

Other clearances by Varian Assoc., Inc.

  • K000922 — PROTON VISION (May 24, 2000)
  • K992762 — BRACHYVISION 6.0 (March 9, 2000)
  • K992751 — SOMAVISION (February 16, 2000)
  • K992753 — CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM (September 3, 1999)
  • K990085 — MILLENNIUM MLC -120 (February 8, 1999)
  • K980601 — VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE (October 21, 1998)
  • K955844 — APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (July 26, 1996)
  • K954467 — CADPLAN BT (March 15, 1996)
  • K955774 — VARIS PORTALVISION (March 15, 1996)
  • K943224 — VARIAN MULTILEAF COLLIMATOR (February 2, 1996)

Other clearances for product code KZR

  • K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (October 6, 1997)
  • K931227 — USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (May 6, 1993)
  • K905538 — COLUMNS LIQUID CHROMATOGRAPHY DPM (January 25, 1991)
  • K861392 — SYVA SOLID PHASE COLUMNS SYSTEM II (June 13, 1986)
  • K860197 — SERIES 410 LC PUMP (March 17, 1986)
  • K851945 — VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (May 24, 1985)
  • K843568 — LIQUID CHROMATOGRAPH 400 (November 20, 1984)
  • K841890 — VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY (June 14, 1984)
  • K840977 — LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (April 19, 1984)
  • K832201 — CHROM-PREP (August 16, 1983)

FDA data resources