510(k) K862300
K862300 is an FDA 510(k) premarket notification submitted by Amresco, Inc. for the device "AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code JGM (Flame Photometry, Potassium), a Class II device regulated under 21 CFR 862.1600. Amresco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 1986
- Date Received
- June 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flame Photometry, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type