510(k) K002674
K002674 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX MICROALBUMIN". The FDA issued a decision of Substantially Equivalent on October 5, 2000. The device falls under product code DDZ (Albumin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2000
- Date Received
- August 28, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Albumin, Fitc, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5040
- Review Panel
- IM
- Submission Type