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510(k) K861735

TIPSEP-TBG ASSAY by Nuclear Diagnostics, Inc. — Product Code CEE

K861735 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "TIPSEP-TBG ASSAY". The FDA issued a decision of Substantially Equivalent on June 13, 1986. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1986
Date Received
May 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroxine-Binding Globulin
Device Class
Class II
Regulation Number
862.1685
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)
  • 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 CEE

  • K952284 — AMERLITE TBG ASSAY (July 26, 1995)
  • K930010 — ACCESS THYROID UPTAKE ASSAY (June 7, 1993)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K905777 — MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT (January 30, 1991)
  • K900240 — DELFIA TBG KIT (March 30, 1990)
  • K896991 — ENZYMUN TEST(R) TBK (March 1, 1990)
  • K893469 — AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT (August 15, 1989)
  • K885034 — T-UPTAKE MICROASSAY (February 2, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K874658 — TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) (December 18, 1987)

FDA data resources