FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K Number: K133751
·
Decision Aug 8, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
26
Review Days
242
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Basic Information
- Device Name
- DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
- K Number
- K133751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diamond Diagnostics, Inc.
- Date Received
- December 9, 2013
- Decision Date
- August 8, 2014
- Product Code
- JIT
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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Other Clearances by Diamond Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K124009 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C | Apr 17, 2013 | Substantially Equivalent |
| K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH | Dec 20, 2012 | Substantially Equivalent |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Aug 30, 2012 | Substantially Equivalent |
| K121140 | PROLYTE ELECTROLYTE ANALYZER | Aug 22, 2012 | Substantially Equivalent |
| K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 | Apr 17, 2012 | Substantially Equivalent |
| K103364 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL | May 6, 2011 | Substantially Equivalent |
| K102959 | PROLYTE ELECTROLYTE ANALYZER | Jan 14, 2011 | Substantially Equivalent |
| K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D | Jun 24, 2010 | Substantially Equivalent |
| K093492 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR | Mar 19, 2010 | Substantially Equivalent |