Serim Leukocyte Esterase Test Strips
FDA 510(k) K000578 · Serim Research Corp.
510(k) numberK000578
Submission
- Device name
- Serim Leukocyte Esterase Test Strips
- Applicant
- Serim Research Corp.
Elkhart, IN, US - Received
- February 22, 2000
- Decision date
- May 5, 2000
- 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 |
| K063295 | Acon Uti Urinary Tract Infection Test StripsLJX · Traditional | ACON Laboratories, Inc. | 10/12/2007SE |
| 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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| K120652 | Rapicide OPA-28 Test StripJOJ · Traditional | 10/12/2012SE |
| K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171JOJ · Traditional | 01/07/2010SE |
| K083295 | Serim Disintek Gta 2.1%, Model: 5164JOJ · Traditional | 03/16/2009SE |
| K082352 | Serim Disintek Opa Test StripJOJ · Traditional | 09/25/2008SE |
| K081370 | Serim Disintek Opa Test StripJOJ · Traditional | 07/11/2008SE |
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Questions and answers
When was Serim Leukocyte Esterase Test Strips cleared by the FDA?
Serim Leukocyte Esterase Test Strips (K000578) received a 510(k) decision of Substantially Equivalent on May 5, 2000, 73 days after the submission was received.
What is the product code of K000578?
The FDA product code is LJX – Test, Urine Leukocyte, a Class I (low risk) device regulated under 21 CFR 864.7675.