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510(k) K812749

ULTRA-DIG by Antibodies, Inc. — Product Code LCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1981
Date Received
September 29, 1981
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 Antibodies, Inc.

  • K890774 — GIARDEIA(TM) (April 4, 1989)
  • K843590 — DETECT-A-STREP (October 30, 1984)
  • K822892 — CORTISOL RIA KIT (November 1, 1982)
  • K812314 — CRITHIDNA ANTI-DNA TEST KIT (September 1, 1981)
  • K802877 — AMIKACIN RIA KIT (December 19, 1980)
  • K800743 — TOBRAMYCIN RIA KIT (April 16, 1980)
  • K791217 — TSH RIA KIT (September 4, 1979)
  • K781655 — NEPHELRATE ANTISERUMS 1GA (November 8, 1978)
  • K781656 — NEPHELRATE ANTISERUMS, IGG (November 8, 1978)
  • K781654 — NEPHELRATE ANTIPERUMS LGM (November 8, 1978)

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)
  • K803047 — I-125 LABELED DIGOXIN (December 22, 1980)
  • K801490 — DIGOXIN EIA KIT (July 14, 1980)
  • K801413 — AMERLEX DIGOXIN RIA KIT (July 8, 1980)