510(k) K992665
K992665 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "MACRA LP(A) ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 26, 1999. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Trinity Biotech USA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 1999
- Date Received
- August 9, 1999
- 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