LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
FDA 510(k) clearance K843727 · decided 1985-01-04
Clearance details
- K-number
- K843727
- Device name
- LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-24
- Decision date
- 1985-01-04
- Days to decision
- 102 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
+ Add to Predicate Builder ◉ Watch Miles Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| SERIM LEUKOCYTE ESTERASE TEST STRIPS (K000578) | Serim Research Corp. | 2000-05-05 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |