510(k) K894805
K894805 is an FDA 510(k) premarket notification submitted by Dms Products, Inc. for the device "RAPIDEC UR". The FDA issued a decision of Substantially Equivalent on Sep 26, 1989. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Dms Products, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 1989
- Date Received
- Jul 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kit, Screening, Urine
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt