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510(k) K780207

LIQUISOL DIGOXIN RIA TEST KIT by Damon Corp. — Product Code DON

K780207 is an FDA 510(k) premarket notification submitted by Damon Corp. for the device "LIQUISOL DIGOXIN RIA TEST KIT". The FDA issued a decision of Substantially Equivalent on February 23, 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. Damon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1978
Date Received
February 7, 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 Damon Corp.

  • K874865 — DAMON D.E.T.E.C.T IMAGE ENHANCER (December 23, 1987)
  • K831826 — ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (July 18, 1983)
  • K820686 — LIQUISOL PROGESTERONE RADIOIMMUNO (April 1, 1982)
  • K802661 — LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT (December 10, 1980)
  • K790250 — LIQUISOL CORTISOL RIA TEST KIT (April 4, 1979)
  • K782124 — IEC CENTRA-7 CENTRIFUGE MODEL 2362 (February 26, 1979)
  • K781012 — RIA TEST KIT SYS. DAMON KIQUISOL FREE (July 27, 1978)
  • K770918 — LIQUI SOL T4 RIA TEST KIT (June 17, 1977)
  • K770606 — ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH (May 6, 1977)
  • K761013 — SPINETTE CENTRIFUGE (November 16, 1976)

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)
  • K781660 — RIA, DIGOXIN (October 24, 1978)

FDA data resources