The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission Urinalysis Reagent Strips (microalbumin/creatinine).
| Device ID | K150330 |
| 510k Number | K150330 |
| Device Name: | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) |
| Classification | Indicator Method, Protein Or Albumin (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 | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-10 |
| Decision Date | 2015-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10722066004392 | K150330 | 000 |