REAGENT STRIPS FOR URINALYSIS
FDA 510(k) clearance K811342 · decided 1981-09-01
Clearance details
- K-number
- K811342
- Device name
- REAGENT STRIPS FOR URINALYSIS
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-12
- Decision date
- 1981-09-01
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- JRE
- Device class
- 1
- Regulation number
- 862.2800
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (K954977) | Teco Diagnostics | 1996-03-11 |
| MODEL 2721 CLINICAL REFRACTOMETER (K941901) | Vee Gee Scientific, Inc. | 1995-01-17 |
| MODEL 2730 CLINICAL REFRACTOMETER (K941906) | Vee Gee Scientific, Inc. | 1995-01-17 |
| MODEL 2740 CLINICAL REFRACTOMETER (K941903) | Vee Gee Scientific, Inc. | 1995-01-17 |
| MODEL 3461 CLINICAL REFRACTOMETER (K941905) | Vee Gee Scientific, Inc. | 1994-12-13 |
| MODEL 3471 CLINICAL REFRACTOMETER (K941902) | Vee Gee Scientific, Inc. | 1994-12-13 |
| MODEL A300CL CLINICAL REFRACTOMETER (K941904) | Vee Gee Scientific, Inc. | 1994-12-13 |
| DILECTRON URINARY CONDUCTIVITY PROBE (K891681) | Gyrus Medical , Ltd. | 1990-05-01 |
| ATAGO URINE SPECIFIC GRAVITY & SERUM (K842168) | Kyoto Diagnostics, Inc. | 1984-07-16 |
| SPECIFIC GRAVITY INSTRUMENT (K831213) | Iris | 1983-06-30 |
| NIKON URINE REFRACTOMER SG-1 (K802959) | Nippon Kogaku, Inc. | 1980-12-19 |
| BIOVATION DIGITAL URINOMETER (K790862) | Biovation, Inc. | 1979-06-28 |
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 |