MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
FDA 510(k) clearance K973451 · decided 1997-09-29
Clearance details
- K-number
- K973451
- Device name
- MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
- Applicant
- Medical Analysis Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-11
- Decision date
- 1997-09-29
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Par recall (Z-0383-2014) | Thermofisher Scientive | 2013-11-22 |