Submission Details
| 510(k) Number | K170587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 28, 2017 |
| Decision Date | July 06, 2017 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
Jul 2017
Decision
128d
Days
Class 1
Risk
About This 510(k) Submission
K170587 is an FDA 510(k) clearance for the On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis, a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 6, 2017, 128 days after receiving the submission on February 28, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.
Device Classification
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1435 |
Manufacturer
Similar Devices — JIN Nitroprusside, Ketones (urinary, Non-quant.)
All 23
K201551 · I-Sens, Inc.
· Sep 2020
K192957 · Vivachek Biotech (Hangzhou) Co., Ltd.
· Jun 2020
K182593 · Apex BioTechnology Corp.
· Dec 2018
K173345 · Taidoc Technology Corporation
· May 2018
K170463 · I-Sens, Inc.
· Apr 2018
K060768 · Abbott Diabetes Care, Inc.
· Apr 2006
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