Home / 510(k) Clearances / K801202

510(k) K801202

DIGOXIN RADIOIMMUNOASSAY KIT by Technia Diagnostics , Ltd. — Product Code LCS

K801202 is an FDA 510(k) premarket notification submitted by Technia Diagnostics , Ltd. for the device "DIGOXIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on June 20, 1980. The device falls under product code LCS (Radioimmunoassay, Digoxin (125-I)), a Class II device regulated under 21 CFR 862.3320. Technia Diagnostics , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1980
Date Received
May 19, 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 Technia Diagnostics , Ltd.

  • K861978 — AUTOFLUOR V (June 10, 1986)
  • K801843 — T3(125) RADIOIMMUNOASSAY KIT (September 16, 1980)
  • K801203 — CORTISOL RADIOIMMUNOASSAY KIT (June 9, 1980)
  • K791361 — T3 UPTAKE RADIOIMMUNOASSAY KIT (August 16, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K790495 — THYROXINE RIA KIT (May 3, 1979)
  • K782024 — RIA KIT, VITAMIN B12 (February 28, 1979)
  • K782025 — GENTAMICIN FLUROIMMUNASSAY KIT (January 26, 1979)

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)

FDA data resources