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510(k) K761272

CENTRIA T4 RIA by Clinical Diagnostics, Inc. — Product Code CDX

K761272 is an FDA 510(k) premarket notification submitted by Clinical Diagnostics, Inc. for the device "CENTRIA T4 RIA". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Clinical Diagnostics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1977
Date Received
December 20, 1976
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 Clinical Diagnostics, Inc.

  • K971653 — GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (January 2, 1998)
  • K951457 — GLUCOCHEK POCKETLAB (February 22, 1996)
  • K940215 — GLUCOCHEK (January 17, 1995)
  • K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I (June 2, 1986)
  • K771813 — CENTRIFICHEM SYS 400 ANALYZER (October 25, 1977)
  • K771118 — CENTRIA SEPARATION COLUMNS TYPE A (July 11, 1977)
  • K771117 — CENTRIA CORTISOL RIA (June 23, 1977)

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