9-WAY URINE TEST WITH ASCORBIC
FDA 510(k) clearance K771755 · decided 1977-10-25
Clearance details
- K-number
- K771755
- Device name
- 9-WAY URINE TEST WITH ASCORBIC
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-16
- Decision date
- 1977-10-25
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JIL
- Device class
- 2
- Regulation number
- 862.1340
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |