510(k) K192730
K192730 is an FDA 510(k) premarket notification submitted by Biosystems S.A. for the device "CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV". The FDA issued a decision of Substantially Equivalent on September 9, 2020. The device falls under product code CHW (Titrimetric With Edta And Indicator, Calcium), a Class II device regulated under 21 CFR 862.1145. Biosystems S.A. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2020
- Date Received
- September 27, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Titrimetric With Edta And Indicator, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type