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510(k) K820274

DIGOXIN RADIOIMMUNOASSAY by American Diagnostic Corp. — Product Code DPB

K820274 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "DIGOXIN RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Feb 23, 1982. The device falls under product code DPB (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.), a Class II device regulated under 21 CFR 862.3320. American Diagnostic Corp. has 38 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 23, 1982
Date Received
Feb 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

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

Other clearances by American Diagnostic Corp.

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

Other clearances for product code DPB

  • K853021 — OPTIMATE DIGOXIN TEST (Aug 7, 1985)
  • K823014 — DIGOXIN KIT (Nov 1, 1982)
  • K821811 — 125I DIGOXIN RADIOIMMUNOASSAY KIT (Jul 2, 1982)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (Nov 13, 1979)
  • K790602 — RIA, DIGNXIN-125-I (Jul 30, 1979)
  • K790540 — RIA TEST KIT, CENTRIA DIGOXIN (Apr 23, 1979)
  • K772306 — 125I DIGOXIN TEST SET (Dec 22, 1977)
  • K771525 — 125 I DIGOXIN RIA KIT (Oct 14, 1977)
  • K760883 — DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY (Nov 19, 1976)

FDA data resources

Source: FDA 510(k) database entry for K820274. Report a data issue: hello@regdatalab.com.