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510(k) K811212

DIGOXIN (RIA) KIT by Immuno Assay Corp. — Product Code DNL

K811212 is an FDA 510(k) premarket notification submitted by Immuno Assay Corp. for the device "DIGOXIN (RIA) KIT". The FDA issued a decision of Substantially Equivalent on May 21, 1981. The device falls under product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. Immuno Assay Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
May 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Immuno Assay Corp.

  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K833745 — RIACOAT T-4 (January 4, 1984)
  • K820089 — TSH (RIA) KIT (January 28, 1982)
  • K820074 — CORTISOL (RIA) KIT (January 28, 1982)
  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K811725 — TBG DIAGNOSTIC KIT (July 10, 1981)
  • K811213 — T3 (RIA) KIT (May 29, 1981)
  • K810857 — T3 UPTAKE KIT (April 8, 1981)
  • K810811 — T4 RIA KIT (April 7, 1981)

Other clearances for product code DNL

  • K852343 — DIG RADIOIMMUNOASSAY TEST SYSTEM (July 9, 1985)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K802841 — DIGOXIN RADIOIMMUNOASSAY KIT (December 18, 1980)
  • K781834 — TEST SET, 125 I-DIGOXIN (January 3, 1979)
  • K781495 — RIANEN ASSAY SYSTEM, 125I KIT (September 14, 1978)
  • K772110 — IN VITRO DIGOXIN RIA TEST (November 22, 1977)

FDA data resources