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510(k) K780672

125 I-T4 RIA REAGENT by Radioimmunoassay, Inc. — Product Code CDX

K780672 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "125 I-T4 RIA REAGENT". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Radioimmunoassay, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1978
Date Received
April 24, 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 Radioimmunoassay, Inc.

  • K802135 — TESTOSTERONE RADIOIMMUNOASSY KIT (October 10, 1980)
  • K800107 — FOLLICLE STIMULATING HORMONE (February 13, 1980)
  • K800106 — LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS (February 13, 1980)
  • K792539 — TRIIODOTHYRONINE RIA SYSTEM (January 16, 1980)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K792154 — THYROID STIMULATING HORMONE (November 13, 1979)
  • K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM (October 30, 1979)
  • K780671 — 125 I-T3 UPTAKE REAGENT (June 6, 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