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510(k) K861320

MMS T4 RIA KIT by Micromedic Systems — Product Code CDX

K861320 is an FDA 510(k) premarket notification submitted by Micromedic Systems for the device "MMS T4 RIA KIT". The FDA issued a decision of Substantially Equivalent on April 24, 1986. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Micromedic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1986
Date Received
April 8, 1986
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 Micromedic Systems

  • K923643 — MEDICOOL (March 31, 1993)
  • K872309 — MICROMEDIC COMBOSTAT LH/FSH KIT (July 31, 1987)
  • K871505 — AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT (May 26, 1987)
  • K871008 — MICROMEDIC NEONATAL T4 KIT (May 26, 1987)
  • K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (May 26, 1987)
  • K870245 — AUTOPAK TSH MONOCLONAL IRMA KIT (April 1, 1987)
  • K862206 — TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (August 4, 1986)
  • K860813 — MICROMEDIC HTSH MONOCLONAL IRMA KIT (July 14, 1986)
  • K861262 — MMS T3 UPTAKE (May 23, 1986)
  • K853127 — MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) (September 16, 1985)

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