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510(k) K830918

I.E.C COLUMN by Berwick Medical Products, Inc. — Product Code KEA

K830918 is an FDA 510(k) premarket notification submitted by Berwick Medical Products, Inc. for the device "I.E.C COLUMN". The FDA issued a decision of Substantially Equivalent on April 27, 1983. The device falls under product code KEA (Resins, Ion-Exchange), 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
April 27, 1983
Date Received
March 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resins, Ion-Exchange
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)
  • K831289 — PREFILLED IEC COLUMNS (June 16, 1983)

Other clearances for product code KEA

  • K890997 — ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (March 28, 1989)
  • K844948 — SYVA SOLID PHASE COLUMNS (August 29, 1985)
  • K842028 — CM-TRISACRYL M DEAE-TRISACRYL M (June 7, 1984)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)
  • K831027 — EXTRELUT QE EXTRACTION COLUMNS (May 16, 1983)
  • K782066 — EXETRELUT (January 3, 1979)
  • K781728 — EXTUBE (December 20, 1978)

FDA data resources