510(k) K181017
K181017 is an FDA 510(k) premarket notification submitted by Monobind, Inc. for the device "Free Testosterone AccuBind ELISA Test System". The FDA issued a decision of Substantially Equivalent on July 20, 2018. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Monobind, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2018
- Date Received
- April 10, 2018
- 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