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510(k) K810966

DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT by E. R. Squibb & Sons, Inc. — Product Code DNL

K810966 is an FDA 510(k) premarket notification submitted by E. R. Squibb & Sons, Inc. for the device "DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 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. E. R. Squibb & Sons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1981
Date Received
April 8, 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 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)
  • K810211 — T3 RIA KIT (February 10, 1981)
  • K803100 — STOMAHESIVE PASTE PROTECTIVE SKIN BARR (January 8, 1981)

Other clearances for product code DNL

  • K852343 — DIG RADIOIMMUNOASSAY TEST SYSTEM (July 9, 1985)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K811212 — DIGOXIN (RIA) KIT (May 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