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510(k) K852291

TIPSEP DIGOXIN RIA by Nuclear Diagnostics, Inc. — Product Code DNL

K852291 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "TIPSEP DIGOXIN RIA". The FDA issued a decision of Substantially Equivalent on June 25, 1985. 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. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
May 29, 1985
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 Nuclear Diagnostics, Inc.

  • K021656 — HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 (June 13, 2002)
  • K002782 — HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION (December 5, 2000)
  • K923917 — ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (February 25, 1994)
  • K932406 — NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (December 2, 1993)
  • K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT (June 17, 1987)
  • K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT (September 26, 1986)
  • K860472 — NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (July 3, 1986)
  • K861735 — TIPSEP-TBG ASSAY (June 13, 1986)
  • K833713 — SERUM THYROTROPIN ASSAY KIT, TIPSEP- (December 29, 1983)
  • K823860 — NUCLIPASE (I125) PANCREATIC LIPASE (April 18, 1983)

Other clearances for product code DNL

  • K852343 — DIG RADIOIMMUNOASSAY TEST SYSTEM (July 9, 1985)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 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