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510(k) K771533

DIGOXIN RIA KIT by G.D. Searle and Co. — Product Code DNJ

K771533 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "DIGOXIN RIA KIT". The FDA issued a decision of Substantially Equivalent on August 25, 1977. The device falls under product code DNJ (Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1977
Date Received
August 10, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)

Other clearances for product code DNJ

  • K771877 — DIGOXIN RIA KIT (October 21, 1977)

FDA data resources