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510(k) K760077

TEST, RIA, SERUM DIGOXIN by Smithkline Diagnostics, Inc. — Product Code DND

K760077 is an FDA 510(k) premarket notification submitted by Smithkline Diagnostics, Inc. for the device "TEST, RIA, SERUM DIGOXIN". The FDA issued a decision of Substantially Equivalent on July 16, 1976. The device falls under product code DND (Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.), a Class II device regulated under 21 CFR 862.3300. Smithkline Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1976
Date Received
June 18, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

Other clearances by Smithkline Diagnostics, Inc.

  • K961062 — FLEXSURE OBT (November 6, 1996)
  • K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS F (June 7, 1996)
  • K934863 — FLEXSURE HP (May 18, 1994)
  • K880499 — HEMOCCULT SENSITIVE TEST (May 23, 1988)
  • K875131 — (SKD) CHOLESTEROL TEST KIT (March 1, 1988)
  • K862849 — HEMOCCULT WIPE TEST (December 9, 1986)
  • K854723 — SKD ELECTROCHEMICAL SYSTEM (ECS) (March 5, 1986)
  • K852841 — RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (July 24, 1985)
  • K821884 — GASTROCCULT TM (October 8, 1982)
  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)

FDA data resources