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FDA 510(k), K172627, David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
FDA 510(k), K172627, David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
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$49.00 USD
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510(K) Number: K172627
Device Name: David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Manufacturer: Runbio BioTech Co.,Ltd
Device Classification Name: kit, test, pregnancy, hcg, over the counter
Regulation Number: 862.1155
Classification Product Code: LCX
Date Received: 09/01/2017
Decision Date: 03/28/2018
Regulation Medical Specialty: Clinical Chemistry
Device Name: David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Manufacturer: Runbio BioTech Co.,Ltd
Device Classification Name: kit, test, pregnancy, hcg, over the counter
Regulation Number: 862.1155
Classification Product Code: LCX
Date Received: 09/01/2017
Decision Date: 03/28/2018
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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