510(k) K030545
K030545 is an FDA 510(k) premarket notification submitted by Denka Seiken Co., Ltd. for the device "CRP-LATEX (II)X2 SEIKEN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on June 2, 2003. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Denka Seiken Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2003
- Date Received
- February 20, 2003
- 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