510(k) K880584
K880584 is an FDA 510(k) premarket notification submitted by Mach Diag. C/O Wichita State University for the device "URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1785. Mach Diag. C/O Wichita State University has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 1988
- Date Received
- February 10, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1785
- Review Panel
- CH
- Submission Type