510(k) K880016
K880016 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "MODIFIED CRP LATEX TEST". The FDA issued a decision of Substantially Equivalent on February 25, 1988. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Sclavo, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1988
- Date Received
- January 5, 1988
- 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