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510(k) K831289

PREFILLED IEC COLUMNS by Berwick Medical Products, Inc. — Product Code DJY

K831289 is an FDA 510(k) premarket notification submitted by Berwick Medical Products, Inc. for the device "PREFILLED IEC COLUMNS". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code DJY (Ion-Exchange Chromatography), a Class I device regulated under 21 CFR 862.2230. Berwick Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
April 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ion-Exchange Chromatography
Device Class
Class I
Regulation Number
862.2230
Review Panel
TX
Submission Type

Other clearances by Berwick Medical Products, Inc.

  • K850800 — DROPSTIRS - PLASTIC DISPOSABLE PIPET (April 2, 1985)
  • K842018 — ISO-SEP SYSTEM (September 28, 1984)
  • K831434 — ISO-SEP SYSTEM (June 30, 1983)
  • K830918 — I.E.C COLUMN (April 27, 1983)

Other clearances for product code DJY

  • K890113 — THE CDI(R) SYSTEM 400 (May 23, 1989)
  • K883615 — LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (December 16, 1988)
  • K881361 — SOLID PHASE EXTRACTION TUBES (August 8, 1988)
  • K850963 — DUPONT PREP TYPE SI EXTRACITON CARTRIDGE (March 25, 1985)
  • K840985 — TRISACRYL GF 05 & TRISACRYL GF 2000 (April 19, 1984)
  • K832198 — HC40/HC75 PREPACKED COLUMS (August 12, 1983)
  • K830692 — DUPONT PREP OD EXTRACTION CARTRIDE (April 5, 1983)
  • K830693 — DUPONT PREP TYPE AS EXTRACTION CARTRIDE (April 5, 1983)
  • K823697 — PREP TYPE A EXTRACTION CARTRIDGE (January 5, 1983)
  • K800061 — BOND ELUT COLUMNS (March 12, 1980)

FDA data resources