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510(k) K833319

BIO-REX 70 RESIN 100-200 MESH PH6.2 by Biosan Laboratories, Inc. — Product Code KEA

K833319 is an FDA 510(k) premarket notification submitted by Biosan Laboratories, Inc. for the device "BIO-REX 70 RESIN 100-200 MESH PH6.2". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code KEA (Resins, Ion-Exchange), a Class I device regulated under 21 CFR 862.2230. Biosan Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
September 26, 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 Biosan Laboratories, Inc.

  • K860642 — PHOTRON VISUAL FIELD ANALYZER (April 15, 1986)
  • K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (November 1, 1985)
  • K832763 — TOBRAMYCIN REAGENT (March 23, 1984)
  • K833193 — RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (February 4, 1984)
  • K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT (January 24, 1984)
  • K833318 — NORMAL GOAT SERUM (January 3, 1984)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833191 — ABNORMAL URINE CONTROL (December 8, 1983)
  • K833192 — NORMAL URINE CONTROL (December 8, 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)
  • K831027 — EXTRELUT QE EXTRACTION COLUMNS (May 16, 1983)
  • K830918 — I.E.C COLUMN (April 27, 1983)
  • K782066 — EXETRELUT (January 3, 1979)
  • K781728 — EXTUBE (December 20, 1978)

FDA data resources