Home / 510(k) Clearances / K842028

510(k) K842028

CM-TRISACRYL M DEAE-TRISACRYL M by Lkb Instruments, Inc. — Product Code KEA

K842028 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "CM-TRISACRYL M DEAE-TRISACRYL M". The FDA issued a decision of Substantially Equivalent on June 7, 1984. The device falls under product code KEA (Resins, Ion-Exchange), a Class I device regulated under 21 CFR 862.2230. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1984
Date Received
May 18, 1984
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 Lkb Instruments, Inc.

  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872955 — DELFIA(TM) FERRITIN KIT (August 21, 1987)
  • K871303 — DELFIA(TM) THYROXINE (T4) KIT (June 17, 1987)
  • K871599 — DELFIA(TM) HIGE KIT (June 12, 1987)
  • K871644 — DELFIA (TM) HTSH KIT (May 12, 1987)
  • K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KIT (February 2, 1987)
  • K864733 — LKB 2260 MACROTOME (January 5, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K863422 — DELFIA(TM) CORTISOL KIT (September 26, 1986)
  • K861195 — DELFIA DIGOXIN (July 11, 1986)

Other clearances for product code KEA

  • K890997 — ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (March 28, 1989)
  • K844948 — SYVA SOLID PHASE COLUMNS (August 29, 1985)
  • 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)
  • K782066 — EXETRELUT (January 3, 1979)
  • K781728 — EXTUBE (December 20, 1978)

FDA data resources