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510(k) K782066

EXETRELUT by Mcb Manufacturing Chemists, Inc. — Product Code KEA

K782066 is an FDA 510(k) premarket notification submitted by Mcb Manufacturing Chemists, Inc. for the device "EXETRELUT". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code KEA (Resins, Ion-Exchange), a Class I device regulated under 21 CFR 862.2230. Mcb Manufacturing Chemists, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1979
Date Received
December 13, 1978
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 Mcb Manufacturing Chemists, Inc.

  • K801212 — WRIGHTS RAPID STAIN (May 30, 1980)
  • K800847 — ENTELLAN (May 8, 1980)
  • K792026 — WRIGHTS RAPID STAIN (November 13, 1979)
  • K791929 — WRIGHTS RAPID STAIN (October 11, 1979)

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)
  • K830918 — I.E.C COLUMN (April 27, 1983)
  • K781728 — EXTUBE (December 20, 1978)

FDA data resources