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FDA DEN: De Novo Decision Summary: DEN220027 - B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System
FDA DEN: De Novo Decision Summary: DEN220027 - B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System
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Request Content: De Novo Decision Summary: Request for DEN220027 decision summary and entire submission records. FDA granted De Novo to B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System on May 18, 2023, assigned regulatory class (Class II) and product code (QWH), but the Decision Summary is not available on the website.
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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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