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510(k) K801413

AMERLEX DIGOXIN RIA KIT by Amersham Corp. — Product Code LCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
June 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I)
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Amersham Corp.

  • K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (February 18, 1992)
  • K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (July 22, 1991)
  • K912766 — AMERLITE CK-MB ASSAY (July 17, 1991)
  • K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (November 2, 1990)
  • K902760 — AMERSHAM TSH CONTROL SERA (July 27, 1990)
  • K901848 — GADOLINIUM-153 BONE DENSITOMETER SOURCES (July 9, 1990)
  • K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) (July 9, 1990)
  • K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 (July 9, 1990)
  • K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) (July 9, 1990)
  • K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (December 12, 1989)

Other clearances for product code LCS

  • K922353 — DIGOXIN COATED TUBE RIA (August 24, 1992)
  • K913562 — QMS - DIGOXIN (August 30, 1991)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS (February 19, 1988)
  • K864802 — DART DIGOXIN ASSAY (February 12, 1987)
  • K820154 — TDX DIGOXIN (February 5, 1982)
  • K812749 — ULTRA-DIG (October 19, 1981)
  • K803047 — I-125 LABELED DIGOXIN (December 22, 1980)
  • K801490 — DIGOXIN EIA KIT (July 14, 1980)