SERIM LEUKOCYTE ESTERASE TEST STRIPS
FDA 510(k) clearance K000578 · decided 2000-05-05
Clearance details
- K-number
- K000578
- Device name
- SERIM LEUKOCYTE ESTERASE TEST STRIPS
- Applicant
- Serim Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-22
- Decision date
- 2000-05-05
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LJX
- Device class
- 1
- Regulation number
- 864.7675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Healgen URS Test Strips (K231045) | Healgen Scientific,, LLC | 2023-06-16 |
| ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295) | ACON Laboratories, Inc. | 2007-10-12 |
| DIASCREEN REAGENT STRIPS (K981555) | Chronimed, Inc. | 1998-06-01 |
| DIASCREEN REAGENT STRIPS (K971976) | Dia-Screen Corp. | 1997-06-17 |
| CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (K873304) | Miles Laboratories, Inc. | 1987-09-11 |
| LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (K843727) | Miles Laboratories, Inc. | 1985-01-04 |
Recalls involving this device
No recalls on record reference this clearance.