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510(k) K932406

NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT by Nuclear Diagnostics, Inc. — Product Code JNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1993
Date Received
May 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Device Class
Class I
Regulation Number
862.1725
Review Panel
CH
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)
  • 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)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K833713 — SERUM THYROTROPIN ASSAY KIT, TIPSEP- (December 29, 1983)
  • K823860 — NUCLIPASE (I125) PANCREATIC LIPASE (April 18, 1983)

Other clearances for product code JNO

  • K110274 — AUTODELFIA NEONATAL IRT KIT (June 10, 2011)
  • K102419 — GSP NEONATAL IRT KIT (3306-001U) (December 16, 2010)
  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861097 — TRYPSIN RIA KIT (May 29, 1986)
  • K811805 — TRYPIN (125I) RIA KIT (August 31, 1981)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)