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510(k) K781660

RIA, DIGOXIN by E. R. Squibb & Sons, Inc. — Product Code DON

K781660 is an FDA 510(k) premarket notification submitted by E. R. Squibb & Sons, Inc. for the device "RIA, DIGOXIN". The FDA issued a decision of Substantially Equivalent on October 24, 1978. The device falls under product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.), a Class II device regulated under 21 CFR 862.3320. E. R. Squibb & Sons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1978
Date Received
September 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by E. R. Squibb & Sons, Inc.

  • K821494 — RIA STAT 16 (June 3, 1982)
  • K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY (March 26, 1982)
  • K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT (March 4, 1982)
  • K820340 — T3 UPTAKE-SQUIBB DIAGNOSTIC KIT (March 4, 1982)
  • K811240 — SUR-FIT LOOP OSTOMY O.R. SET (June 16, 1981)
  • K811239 — SUR-FIT DISPOSABLE CONVEX INSERT (June 9, 1981)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K811163 — SUR-FIT DISPOSABLE FANGE CAP (May 21, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K810211 — T3 RIA KIT (February 10, 1981)

Other clearances for product code DON

  • K902861 — CIBA CORNING ACS DIGOXIN IMMUNOASSAY (September 10, 1990)
  • K881679 — CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY (July 8, 1988)
  • K840461 — MAGIC 125I DIGOXIN RADIOIMMUNOASSAY (March 23, 1984)
  • K830533 — PHASE II DIGOXIN RADIOIMMUNOASSAY KIT (April 5, 1983)
  • K822053 — ZETAPHASE-DIG (July 27, 1982)
  • K821000 — ENZYMUNE-TEST DIGOXIN (April 26, 1982)
  • K810296 — DIGOXIN RIA ASSAY (February 19, 1981)
  • K803075 — DIGOXIN RIABEAD DIAGNOSTIC KIT (December 22, 1980)
  • K791549 — TECHNICON STAR SYSTEM (September 27, 1979)
  • K780475 — DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (April 24, 1978)

FDA data resources