510(k) K191533
K191533 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG". The FDA issued a decision of Substantially Equivalent on August 28, 2019. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2019
- Date Received
- June 10, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device Class
- Class I
- Regulation Number
- 862.1680
- Review Panel
- CH
- Submission Type