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Sparse Sample Pk Profile And Dosing Software

Baxalta US Inc.

The following data is part of a premarket notification filed by Baxalta Us Inc. with the FDA for 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 .

Pre-market Notification Details

• Device ID: BK170028
• 510k Number: BK170028
• Device Name: 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
• Classification: Sparse Sample Pk Profile And Dosing Software
• Applicant: Baxalta US Inc. one Baxter Way Westlake Village, CA 91362
• Product Code: PHY
• CFR Regulation Number: 868.1890 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-24
• Decision Date: 2017-12-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850025688826	BK170028	0
00850025688819	BK170028	0