510(k) K812834
K812834 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "CREATININE REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 3, 1981. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1981
- Date Received
- October 9, 1981
- 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