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510(k) Contents – FERTILITE OV (K020808, Pheromone Sciences Corporation)
510(k) Contents – FERTILITE OV (K020808, Pheromone Sciences Corporation)
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510(K) Number: K020808
Device Name: FERTILITE OV
Manufacturer: PHEROMONE SCIENCES CORP.
Device Classification Name: Test, Luteinizing Hormone (Lh), Over The Counter
Regulation Number: 862.1485
Classification Product Code: NGE
Date Received: 03/12/2002
Decision Date: 09/23/2002
Regulation Medical Specialty: Clinical Chemistry
Request Contents: All contents of K020808, Device name: FERTILITE OV Manufacturer name: Pheromone Sciences Corporation
Device Name: FERTILITE OV
Manufacturer: PHEROMONE SCIENCES CORP.
Device Classification Name: Test, Luteinizing Hormone (Lh), Over The Counter
Regulation Number: 862.1485
Classification Product Code: NGE
Date Received: 03/12/2002
Decision Date: 09/23/2002
Regulation Medical Specialty: Clinical Chemistry
Request Contents: All contents of K020808, Device name: FERTILITE OV Manufacturer name: Pheromone Sciences Corporation
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- 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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