MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
FDA 510(k) clearance K890534 · decided 1989-03-08
Clearance details
- K-number
- K890534
- Device name
- MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
- Applicant
- Fisher Scientific Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 1989-01-26
- Decision date
- 1989-03-08
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Orangeburg, NY, 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 |
|---|---|---|
| FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001) | Fisher Scientific Co., LLC | 1979-07-18 |