Submission Details
| 510(k) Number | K063295 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2006 |
| Decision Date | October 12, 2007 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ACON UTI URINARY TRACT INFECTION TEST STRIPS
Oct 2007
Decision
345d
Days
Class 1
Risk
About This 510(k) Submission
K063295 is an FDA 510(k) clearance for the ACON UTI URINARY TRACT INFECTION TEST STRIPS, a Test, Urine Leukocyte (Class I — General Controls, product code LJX), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 12, 2007, 345 days after receiving the submission on November 1, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7675.
Device Classification
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.7675 |
Manufacturer
Similar Devices — LJX Test, Urine Leukocyte
K231045 · Healgen Scientific, LLC
· Jun 2023
K000578 · Serim Research Corp.
· May 2000
K981555 · Chronimed, Inc.
· Jun 1998
K971976 · Dia-Screen Corp.
· Jun 1997
K873304 · Miles Laboratories, Inc.
· Sep 1987
K843727 · Miles Laboratories, Inc.
· Jan 1985
More from ACON Laboratories, Inc.
View all
K251697
· GTY · Nov 2025
K251749
· SCA · Oct 2025
K250085
· NBW · Oct 2025
K250377
· SCA · May 2025
K232715
· LCX · May 2024