510(k) K874389
K874389 is an FDA 510(k) premarket notification submitted by Sakers, Inc. for the device "CRACK-IT CHAP SCREEN". The FDA issued a decision of Substantially Equivalent on February 7, 1989. The device falls under product code DMN (Thin Layer Chromatography, Cocaine), a Class II device regulated under 21 CFR 862.3250. Sakers, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1989
- Date Received
- October 27, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Cocaine
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type