510(k) K031267
K031267 is an FDA 510(k) premarket notification submitted by Environmental Test Systems, Inc. for the device "STERICHEK BICARB PH REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on December 23, 2003. The device falls under product code MNV (Strip, Dialysate Ph Indicator), a Class II device regulated under 21 CFR 876.5820. Environmental Test Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2003
- Date Received
- April 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Dialysate Ph Indicator
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type