510(k) K910553
K910553 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE APOLIPOPROTEIN STANDARD". The FDA issued a decision of Substantially Equivalent on May 8, 1991. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1991
- Date Received
- February 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Lipoprotein, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5580
- Review Panel
- IM
- Submission Type