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510(k) K851445

COLOR OVULATION TEST by Nms Pharmaceuticals, Inc. — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1985
Date Received
April 11, 1985
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 Nms Pharmaceuticals, Inc.

  • K861202 — TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (January 9, 1987)
  • K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (October 10, 1986)
  • K860828 — FORETEL, COLOR OVULATION TEST (August 4, 1986)
  • K853925 — QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA (December 2, 1985)
  • K850431 — EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL (June 17, 1985)
  • K850786 — TOTAL HIGE ENZYME IMMUNOASSAY (April 12, 1985)
  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)
  • K842499 — NMS 1043 ENZYME IMMUNOASSAY KIT (September 14, 1984)

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  • 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)