510(k) K860662
K860662 is an FDA 510(k) premarket notification submitted by Amresco, Inc. for the device "AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Amresco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1986
- Date Received
- February 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercuric Thiocyanate, Colorimetry, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type