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510(k) K801490

DIGOXIN EIA KIT by M.A. Bioproducts — Product Code LCS

K801490 is an FDA 510(k) premarket notification submitted by M.A. Bioproducts for the device "DIGOXIN EIA KIT". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code LCS (Radioimmunoassay, Digoxin (125-I)), a Class II device regulated under 21 CFR 862.3320. M.A. Bioproducts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
June 26, 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 M.A. Bioproducts

  • K822883 — HERPELISA KIT (July 26, 1983)
  • K823804 — MYCOPLASMELISA TEST KIT (May 25, 1983)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)
  • K830615 — CYTOMEGELISA STAT (May 9, 1983)
  • K823805 — VARICELISA TEST KIT (May 5, 1983)
  • K821967 — CHLAMYDELISA TEST KIT (August 3, 1982)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)
  • K813221 — TOXOELISA TEST KIT (January 26, 1982)
  • K812531 — CELL CULTURE REAGENTS (October 23, 1981)
  • K812123 — CYTOMEGELISA TEST KIT (September 23, 1981)

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)
  • K801413 — AMERLEX DIGOXIN RIA KIT (July 8, 1980)

FDA data resources