QUALICHECK TM
FDA 510(k) clearance K771444 · decided 1977-08-16
Clearance details
- K-number
- K771444
- Device name
- QUALICHECK TM
- Applicant
- The London Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-01
- Decision date
- 1977-08-16
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JJS
- Device class
- 1
- Regulation number
- 862.1660
- 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
| Record | Firm | Date |
|---|---|---|
| Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used recall (Z-0608-2013) | Radiometer America Inc | 2012-12-21 |