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510(k) K780707

T4-RIA KIT by Clinical Bioresearch — Product Code CDX

K780707 is an FDA 510(k) premarket notification submitted by Clinical Bioresearch for the device "T4-RIA KIT". The FDA issued a decision of Substantially Equivalent on June 14, 1978. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Clinical Bioresearch has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1978
Date Received
April 25, 1978
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 Bioresearch

  • K780499 — CBR-T3RIA KIT (May 4, 1978)
  • K780500 — CBR-T3 UPTAKE KIT (May 3, 1978)
  • K780498 — CBR-DIGOXIN ANTISERUM (April 5, 1978)

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