510(k) K970302
K970302 is an FDA 510(k) premarket notification submitted by Perimmune, Inc. for the device "APO-TEK LP(A)". The FDA issued a decision of Substantially Equivalent on November 10, 1997. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Perimmune, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 1997
- Date Received
- January 27, 1997
- 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