The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Ketone Reagent Strips For Urinalysis, Healthy Me Ketone Reagent Strips For Urinalysis.
| Device ID | K170587 |
| 510k Number | K170587 |
| Device Name: | On Call Ketone Reagent Strips For Urinalysis, Healthy Me Ketone Reagent Strips For Urinalysis |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, CA 92121 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810038632445 | K170587 | 000 |
| 00810038631431 | K170587 | 000 |