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510(k) K812749

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

K812749 is an FDA 510(k) premarket notification submitted by Antibodies, Inc. for the device "ULTRA-DIG". The FDA issued a decision of Substantially Equivalent on October 19, 1981. The device falls under product code LCS (Radioimmunoassay, Digoxin (125-I)), a Class II device regulated under 21 CFR 862.3320. Antibodies, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K781654 — NEPHELRATE ANTIPERUMS LGM (November 8, 1978)
  • K781656 — NEPHELRATE ANTISERUMS, IGG (November 8, 1978)
  • K781653 — NEPHELRATE ANTISERUMS C3C (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)

FDA data resources