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510(k) K874623

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 by Cyberfluor, Inc. — Product Code CDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
November 10, 1987
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 Cyberfluor, Inc.

  • K923410 — FIAGEN PROGESTERONE (December 3, 1992)
  • K905656 — FLAGEN TRIIODOTHYRONINE (T3) ASSAY (January 23, 1991)
  • K904539 — FLAGEN TM FREE T4 (November 30, 1990)
  • K900621 — FIAGEN(TM) HLH.S (March 1, 1990)
  • K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-402 (November 8, 1989)
  • K895396 — CYBERFLUOR FIAGEN TSH (October 31, 1989)
  • K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K883182 — FIAGEN RUBELLA IGG (October 31, 1988)

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)