510(k) K180074
K180074 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme Lipoprotein (a) Assay". The FDA issued a decision of Substantially Equivalent on March 22, 2018. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 2018
- Date Received
- January 10, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5600
- Review Panel
- IM
- Submission Type