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510(k) K844164

REACTIFS, IBF ULTROGELS ACA & ULTROGELS A by Lkb Instruments, Inc. — Product Code DII

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1984
Date Received
October 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Columns, Glc
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type

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  • 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 DII

  • K874824 — CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (January 21, 1988)
  • K862542 — CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (August 4, 1986)
  • K841712 — CAPILLARY GAS CHROMATOGRAPHIC COLUMNS (May 21, 1984)
  • K791893 — 19091-XXXXX SER. OF GLASS CAPILLARY COL. (October 30, 1979)