510(k) BK130020
- Device
- SOFTWARE, BLOOD VIRUS APPLICATION
- Applicant
- Abbott Laboratories
- 510(k) number
- BK130020
- Product code
- MTQ
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2013-05-14
- Date received
- 2013-04-16
- Regulation
- 510(k) Premarket Notification
- Classification name
- Software, Blood Virus Applications
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Special
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases