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 |