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510(k) K792599

TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY by Nuclear Diagnostics, Inc. — Product Code CDX

K792599 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
December 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
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)
  • 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)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K833713 — SERUM THYROTROPIN ASSAY KIT, TIPSEP- (December 29, 1983)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources