510(k) K012422
K012422 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY D-DIMER CONTROLS". The FDA issued a decision of Substantially Equivalent on August 21, 2001. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2001
- Date Received
- July 30, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Plasma, Abnormal
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type