Home / 510(k) Clearances / K802841

510(k) K802841

DIGOXIN RADIOIMMUNOASSAY KIT by American Diagnostic Corp. — Product Code DNL

K802841 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "DIGOXIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on December 18, 1980. 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. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
November 12, 1980
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 American Diagnostic Corp.

  • K162589 — Adscope 658 Electronic Stethoscope (March 10, 2017)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (May 15, 2006)
  • K012304 — ADC 656 ELECTRONIC STETHOSCOPE (November 1, 2001)
  • K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS (January 27, 1997)
  • K940686 — ELECTRONIC THERMOMETERS (July 8, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 1994)
  • K932145 — COAGULATION REFERENCE PLASMA, NORMAL (October 18, 1993)
  • K894169 — BIOTEL MICROALBUMINURIA (TM) (September 18, 1989)
  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)

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)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • 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