510(k) Contents – Instant-View LH Ovulation Predicting Test (K022829, Alfa Scientific Designs, Inc.)

510(k) Contents – Instant-View LH Ovulation Predicting Test (K022829, Alfa Scientific Designs, Inc.)

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510(K) Number: K022829
Device Name: INSTANT-VIEW LH OVULATION PREDICTING TEST
Manufacturer: ALFA SCIENTIFIC DESIGNS, INC.
Device Classification Name: Radioimmunoassay, Luteinizing Hormone
Regulation Number: 862.1485
Classification Product Code: CEP
Date Received: 08/26/2002
Decision Date: 11/05/2002
Regulation Medical Specialty: Clinical Chemistry
Request Contents: All contents of K022829, Device name: Instant-View LH Ovulation Predicting Test Manufacturer name: Alfa Scientific Designs, Inc.
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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