QUANTIMETRIX URINE DIPSTICK CONTROL
FDA 510(k) clearance K874890 · decided 1988-01-21
Clearance details
- K-number
- K874890
- Device name
- QUANTIMETRIX URINE DIPSTICK CONTROL
- Applicant
- Quantimetrix Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1987-12-01
- Decision date
- 1988-01-21
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hawthorne, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 recall (Z-0138-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2024-10-22 |
| Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is recall (Z-0514-2009) | Quantimetrix Corporation | 2009-01-17 |