510(k) K011499
K011499 is an FDA 510(k) premarket notification submitted by Sun Biomedical Laboratories, Inc. for the device "VISUALINE AMPHETAMINE DIPSTRIP ASSAY". The FDA issued a decision of Substantially Equivalent on July 17, 2001. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Sun Biomedical Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2001
- Date Received
- May 15, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type