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510(k) K840188

MICROMEDIC LH & FSH RIA KIT by Micromedic Systems — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
January 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
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)
  • K861320 — MMS T4 RIA KIT (April 24, 1986)

Other clearances for product code CEP

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  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (November 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (February 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (December 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (August 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)