510(k) K874390
K874390 is an FDA 510(k) premarket notification submitted by Sakers, Inc. for the device "CRACK-IT CANNABINOID SCREEN". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Sakers, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1989
- Date Received
- October 27, 1987
- 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