510(k) K993441
K993441 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY ALPHA-1 AG". The FDA issued a decision of Substantially Equivalent on November 24, 1999. The device falls under product code LKL (Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1999
- Date Received
- October 12, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5420
- Review Panel
- IM
- Submission Type