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510(k) K872955

DELFIA(TM) FERRITIN KIT by Lkb Instruments, Inc. — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1987
Date Received
July 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class
Class II
Regulation Number
866.5340
Review Panel
CH
Submission Type

Other clearances by Lkb Instruments, Inc.

  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 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)
  • K862044 — DELFIA (TM) HCG KIT (July 11, 1986)

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  • K964282 — TINA-QUANT FERRITIN ASSAY (July 30, 1997)
  • K971833 — ELECSYS FERRITIN (June 2, 1997)
  • K963498 — FERR FLEX REAGENT CARTRIDGE (January 24, 1997)
  • K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY (May 16, 1995)
  • K925848 — IMMULITE FERRITIN (January 13, 1993)
  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)