510(k) Contents – CLEARPLAN EASY FERTILITY MONITOR (K981207, Unipath Ltd.)

510(k) Contents – CLEARPLAN EASY FERTILITY MONITOR (K981207, Unipath Ltd.)

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510(K) Number: K981207
Device Name: CLEARPLAN EASY FERTILITY MONITOR
Manufacturer: UNIPATH LTD.
Device Classification Name: Test, Luteinizing Hormone (Lh), Over The Counter
Regulation Number: 862.1485
Classification Product Code: NGE
Date Received: 04/02/1998
Decision Date: 10/28/1998
Regulation Medical Specialty: Clinical Chemistry
Request Contents: All contents of K981207, Device name: CLEARPLAN EASY FERTILITY MONITOR Manufacturer name: UNIPATH LTD.
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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