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510(k) K820886

THYROXINE T4 KIT by Pcl-Ria, Inc. — Product Code CDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
March 30, 1982
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 Pcl-Ria, Inc.

  • K830526 — B-GCG SYSTEM BY RIA (April 5, 1983)
  • K822935 — THYROID STIMULATING HORMONE (November 1, 1982)
  • K823014 — DIGOXIN KIT (November 1, 1982)
  • K822612 — T3 UPTAKE KITS (September 30, 1982)
  • K820358 — FOLLICLE STIMULATING HORMONE KIT (March 26, 1982)
  • K820357 — LUTEINIZING HORMONE KIT (March 25, 1982)
  • K812666 — THYROXINE (T4) 125I (October 2, 1981)
  • K810867 — FOLLICLE STIMULATING HORMONE (FSH) (April 14, 1981)
  • K810852 — FOLLICLE STIMULATING HORMONE ANTISERUM (April 8, 1981)
  • K810741 — LUTEINIZING HORMONE (March 31, 1981)

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)