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FDA 510(k), K171136, LIA Pregnancy Test
FDA 510(k), K171136, LIA Pregnancy Test
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510(K) Number: K171136
Device Name: LIA Pregnancy Test
Manufacturer: LIA Diagnostics
Device Classification Name: kit, test, pregnancy, hcg, over the counter
Regulation Number: 862.1155
Classification Product Code: LCX
Date Received: 04/17/2017
Decision Date: 11/20/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: LIA Pregnancy Test
Manufacturer: LIA Diagnostics
Device Classification Name: kit, test, pregnancy, hcg, over the counter
Regulation Number: 862.1155
Classification Product Code: LCX
Date Received: 04/17/2017
Decision Date: 11/20/2017
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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