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FDA 510(k), K953581, FIRST RESPONSE OVULATION PREDICTOR TEST
FDA 510(k), K953581, FIRST RESPONSE OVULATION PREDICTOR TEST
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510(K) Number: K953581
Device Name: FIRST RESPONSE OVULATION PREDICTOR TEST
Manufacturer: ARMKEL, LLC.
Device Classification Name: Radioimmunoassay, Luteinizing Hormone
Regulation Number: 862.1485
Classification Product Code: CEP
Date Received: 08/01/1995
Decision Date: 10/03/1995
Regulation Medical Specialty: Clinical Chemistry
Device Name: FIRST RESPONSE OVULATION PREDICTOR TEST
Manufacturer: ARMKEL, LLC.
Device Classification Name: Radioimmunoassay, Luteinizing Hormone
Regulation Number: 862.1485
Classification Product Code: CEP
Date Received: 08/01/1995
Decision Date: 10/03/1995
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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