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510(k) K922353

DIGOXIN COATED TUBE RIA by Monobind — Product Code LCS

K922353 is an FDA 510(k) premarket notification submitted by Monobind for the device "DIGOXIN COATED TUBE RIA". The FDA issued a decision of Substantially Equivalent on August 24, 1992. The device falls under product code LCS (Radioimmunoassay, Digoxin (125-I)), a Class II device regulated under 21 CFR 862.3320. Monobind has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
May 19, 1992
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

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  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K020548 — FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (April 5, 2002)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (September 2, 1997)
  • K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (July 3, 1997)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K971780 — THYROTROPIN(TSH) ELISA (June 24, 1997)

Other clearances for product code LCS

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

FDA data resources