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510(k) K841891

VARIAN 3300 & 3400 GAS CHROMATOGRAPHS by Varian Assoc., Inc. — Product Code KZQ

K841891 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VARIAN 3300 & 3400 GAS CHROMATOGRAPHS". The FDA issued a decision of Substantially Equivalent on July 9, 1984. The device falls under product code KZQ (Chromatography(Gas), Clinical Use), a Class I device regulated under 21 CFR 862.2250. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1984
Date Received
May 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography(Gas), Clinical Use
Device Class
Class I
Regulation Number
862.2250
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 KZQ

  • K872122 — 8000 SERIES GAS CHROMATOGRAPHS (June 17, 1987)
  • K832962 — GAS CHROMATOGRAPH 5890A (October 28, 1983)
  • K831387 — HS-100 HEADSPACE SAMPLING ACCESSORY (August 24, 1983)
  • K830147 — SIGMA 300 GAS CHROMATROGRAPH (February 7, 1983)
  • K820283 — SIGMA 2000 GAS CHROMATOGRAPH (February 23, 1982)
  • K820025 — TRACE ANALYTICAL REDUCTION GAS ANALYZ (February 15, 1982)
  • K820071 — MODEL 5790 GAS CHROMATOGRAPH (January 28, 1982)
  • K801745 — VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (August 20, 1980)
  • K791138 — 5880 SERIES OF GAS CHROMATOGRAPHS (July 24, 1979)
  • K770639 — DETECTOR, IR, MODEL GC-33 (June 24, 1977)

FDA data resources