Leukostix Reagent Strips for Urinalysis
FDA 510(k) K843727 · Miles Laboratories, Inc.
510(k) numberK843727
Submission
- Device name
- Leukostix Reagent Strips for Urinalysis
- Applicant
- Miles Laboratories, Inc.
Elkhart, IN, US - Received
- September 24, 1984
- Decision date
- January 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Leukostix Reagent Strips for Urinalysis cleared by the FDA?
Leukostix Reagent Strips for Urinalysis (K843727) received a 510(k) decision of Substantially Equivalent on January 4, 1985, 102 days after the submission was received.
What is the product code of K843727?
The FDA product code is LJX – Test, Urine Leukocyte, a Class I (low risk) device regulated under 21 CFR 864.7675.