510(k) K982087
K982087 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE CRP T CONTROL N". The FDA issued a decision of Substantially Equivalent on August 18, 1998. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1998
- Date Received
- June 15, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- C-Reactive Protein, Antigen, Antiserum, And Control
- Device Class
- Class II
- Regulation Number
- 866.5270
- Review Panel
- IM
- Submission Type