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510(k) K905538

COLUMNS LIQUID CHROMATOGRAPHY DPM by Millpore Corp. — Product Code KZR

K905538 is an FDA 510(k) premarket notification submitted by Millpore Corp. for the device "COLUMNS LIQUID CHROMATOGRAPHY DPM". The FDA issued a decision of Substantially Equivalent on January 25, 1991. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), a Class I device regulated under 21 CFR 862.2260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
December 11, 1990
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

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  • 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)
  • K802725 — VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (December 11, 1980)

FDA data resources