CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
K-Number: K192730 · 2020-09-09
ApplicantBiosystems S.A.
Decision Date2020-09-09
Product CodeCHW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is a medical device manufactured by Biosystems S.A.. It received FDA 510(k) clearance on 2020-09-09 under approval number K192730. The device is classified under product code CHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by Biosystems S.A.. The 510(k) number is K192730.
When was CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV approved by the FDA?
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV received FDA 510(k) clearance on 2020-09-09, under approval number K192730.
What company makes CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is manufactured by Biosystems S.A..
What is the FDA product code for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?
The FDA product code for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is CHW.
Other Devices by Biosystems S.A.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.