CLINITEK 50 URINE CHEMISTRY ANALYZER
FDA 510(k) clearance K960546 · decided 1996-06-12
Clearance details
- K-number
- K960546
- Device name
- CLINITEK 50 URINE CHEMISTRY ANALYZER
- Applicant
- Bayer Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-08
- Decision date
- 1996-06-12
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and recall (Z-1051-04) | Bayer Healthcare LLC | 2004-07-20 |
| Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and recall (Z-0911-03) | Bayer HealthCare LLC, Diagnostics Div | 2003-06-21 |