Submission Details
| 510(k) Number | K150330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 10, 2015 |
| Decision Date | April 30, 2015 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
Apr 2015
Decision
79d
Days
Class 1
Risk
About This 510(k) Submission
K150330 is an FDA 510(k) clearance for the Mission Urinalysis Reagent Strips (Microalbumin/Creatinine), a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on April 30, 2015, 79 days after receiving the submission on February 10, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.
Device Classification
| Product Code | JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1645 |
Manufacturer
Similar Devices — JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
All 37
K222921 · Healthy.Io, Ltd.
· Sep 2023
K210069 · Healthy.Io, Ltd.
· Jul 2022
K061419 · Teco Diagnostics
· Jan 2007
K022538 · Diagnostic Chemicals, Ltd. (Usa)
· Aug 2002
K001810 · Flexsite Diagnostics, Inc.
· Aug 2000
K994035 · Diagnostic Chemicals , Ltd.
· Feb 2000
More from ACON Laboratories, Inc.
View all
K251697
· GTY · Nov 2025
K251749
· SCA · Oct 2025
K250085
· NBW · Oct 2025
K250377
· SCA · May 2025
K232715
· LCX · May 2024