MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
FDA 510(k) clearance K112834 · decided 2012-03-28
Clearance details
- K-number
- K112834
- Device name
- MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
- Applicant
- Verichem Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-28
- Decision date
- 2012-03-28
- Days to decision
- 182 days
- Clearance type
- Abbreviated
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Providence, RI, US
- Third-party review
- No
- Expedited review
- No
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| RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (K122398) | Siemens Healthcare Diagnostics, Inc. | 2012-10-12 |
| ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 (K112029) | Elitechgroup | 2011-08-30 |
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Recalls involving this device
No recalls on record reference this clearance.