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510(k) K782103

RIA KIT, NEONATAL T4 by Serono Laboratories, Inc. — Product Code CDX

K782103 is an FDA 510(k) premarket notification submitted by Serono Laboratories, Inc. for the device "RIA KIT, NEONATAL T4". The FDA issued a decision of Substantially Equivalent on January 17, 1979. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Serono Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1979
Date Received
December 15, 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 Serono Laboratories, Inc.

  • K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
  • K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT (March 31, 1981)
  • K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- (March 27, 1981)
  • K792043 — PAP-CHECK RIA KIT (October 30, 1979)
  • K790679 — ESTRADIOL RIA KIT (May 23, 1979)
  • K790440 — PROGESTERONE (May 3, 1979)
  • K782143 — RIA KIT, GLUCOSE (February 22, 1979)
  • K781733 — RIA KIT, PREG-STAT (December 20, 1978)
  • K781285 — INSULIN RIA KIT (August 14, 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