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510(k) K860472

NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS by Nuclear Diagnostics, Inc. — Product Code IWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1986
Date Received
February 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

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  • 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)
  • 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)

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