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510(k) K822053

ZETAPHASE-DIG by Biological & Diagnostic Products — Product Code DON

K822053 is an FDA 510(k) premarket notification submitted by Biological & Diagnostic Products for the device "ZETAPHASE-DIG". The FDA issued a decision of Substantially Equivalent on July 27, 1982. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1982
Date Received
July 13, 1982
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 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)
  • 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)
  • K781660 — RIA, DIGOXIN (October 24, 1978)
  • K780475 — DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (April 24, 1978)

FDA data resources