SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
FDA 510(k) clearance K050652 · decided 2005-04-06
Clearance details
- K-number
- K050652
- Device name
- SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
- Applicant
- Arkray, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-14
- Decision date
- 2005-04-06
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cortlandt Manor, NY, US
- Third-party review
- No
- Expedited review
- No
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| DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K132638) | Siemens Healthcare Diagnostics, Inc. | 2014-01-27 |
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| EASYRA CREATININE REAGENT (K123586) | Medica Corporation | 2013-05-15 |
| ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL (K110530) | HORIBA ABX SAS | 2012-04-30 |
| CREATININE (K083809) | Abbott Laboratories | 2009-04-07 |
| ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H (K072115) | Horiba Abx | 2007-11-30 |
Recalls involving this device
No recalls on record reference this clearance.