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510(k) K871505

AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT by Micromedic Systems — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1987
Date Received
April 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Micromedic Systems

  • K923643 — MEDICOOL (March 31, 1993)
  • K872309 — MICROMEDIC COMBOSTAT LH/FSH KIT (July 31, 1987)
  • K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (May 26, 1987)
  • K871008 — MICROMEDIC NEONATAL T4 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)
  • K861320 — MMS T4 RIA KIT (April 24, 1986)
  • K853127 — MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) (September 16, 1985)

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