The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control.
| Device ID | K103387 |
| 510k Number | K103387 |
| Device Name: | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-18 |
| Decision Date | 2011-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066001912 | K103387 | 000 |