Acon Uti Urinary Tract Infection Test Strips
FDA 510(k) K063295 · ACON Laboratories, Inc.
510(k) numberK063295
Submission
- Device name
- Acon Uti Urinary Tract Infection Test Strips
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- November 1, 2006
- Decision date
- October 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJX – Test, Urine Leukocyte
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.7675
- Specialty
- Hematology
Other 510(k)s with product code LJX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231045 | Healgen URS Test StripsLJX · Traditional | Healgen Scientific,, LLC | 06/16/2023SE |
| K000578 | Serim Leukocyte Esterase Test StripsLJX · Traditional | Serim Research Corp. | 05/05/2000SE |
| K981555 | Diascreen Reagent StripsLJX · Traditional | Chronimed, Inc. | 06/01/1998SE |
| K971976 | Diascreen Reagent StripsLJX · Traditional | Dia-Screen Corp. | 06/17/1997SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | Miles Laboratories, Inc. | 09/11/1987SE |
| K843727 | Leukostix Reagent Strips for UrinalysisLJX · Traditional | Miles Laboratories, Inc. | 01/04/1985SE |
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Questions and answers
When was Acon Uti Urinary Tract Infection Test Strips cleared by the FDA?
Acon Uti Urinary Tract Infection Test Strips (K063295) received a 510(k) decision of Substantially Equivalent on October 12, 2007, 345 days after the submission was received.
What is the product code of K063295?
The FDA product code is LJX – Test, Urine Leukocyte, a Class I (low risk) device regulated under 21 CFR 864.7675.