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FDA 510(k), K020801, QUICKVUE ONE-STEP HCG-COMBO
FDA 510(k), K020801, QUICKVUE ONE-STEP HCG-COMBO
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510(K) Number: K020801
Device Name: QUICKVUE ONE-STEP HCG-COMBO
Manufacturer: QUIDEL CORP.
Device Classification Name: visual, pregnancy hcg, prescription use
Regulation Number: 862.1155
Classification Product Code: JHI
Date Received: 03/12/2002
Decision Date: 05/17/2002
Regulation Medical Specialty: Clinical Chemistry
Device Name: QUICKVUE ONE-STEP HCG-COMBO
Manufacturer: QUIDEL CORP.
Device Classification Name: visual, pregnancy hcg, prescription use
Regulation Number: 862.1155
Classification Product Code: JHI
Date Received: 03/12/2002
Decision Date: 05/17/2002
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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