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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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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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