510(k) K800685
K800685 is an FDA 510(k) premarket notification submitted by Diagnostic Solutions, Inc. for the device "REAGENT FOR DETERM. CREATININE IN H/SERU". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Diagnostic Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1980
- Date Received
- March 26, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alkaline Picrate, Colorimetry, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type