510(k) K910552
K910552 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE REAGENT FOR APOLIPOPROTEIN B". The FDA issued a decision of Substantially Equivalent on May 7, 1991. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1991
- Date Received
- February 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apolipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type