The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Uti Urinary Tract Infection Test Strips.
| Device ID | K063295 |
| 510k Number | K063295 |
| Device Name: | ACON UTI URINARY TRACT INFECTION TEST STRIPS |
| Classification | Test, Urine Leukocyte |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Jinn-nan Lin |
| Correspondent | Jinn-nan Lin ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | LJX |
| CFR Regulation Number | 864.7675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066003404 | K063295 | 000 |
| 50096295135850 | K063295 | 000 |
| 20682607651003 | K063295 | 000 |
| 00023513000039 | K063295 | 000 |
| 00860002060484 | K063295 | 000 |
| 00850024942073 | K063295 | 000 |
| 00023513487441 | K063295 | 000 |
| 00810038633473 | K063295 | 000 |
| 10810038631445 | K063295 | 000 |