510(k) K150330
K150330 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)". The FDA issued a decision of Substantially Equivalent on April 30, 2015. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2015
- Date Received
- February 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1645
- Review Panel
- CH
- Submission Type