510(k) K963606
K963606 is an FDA 510(k) premarket notification submitted by Sun Biomedical Laboratories, Inc. for the device "VISUALINE COMBO V (COCAINE/THC) TEST". The FDA issued a decision of Substantially Equivalent on October 30, 1996. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Sun Biomedical Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1996
- Date Received
- September 9, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cannabinoids
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type