STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE— 510(k) K013850
Substantially EquivalentDiamond Diagnostics, Inc.
FDA 510(k) clearance K013850 for STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE, Substantially Equivalent on 2001-12-21. Applicant: Diamond Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Diamond Diagnostics, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
Recent devices under product code JIT
view allMore clearances from Diamond Diagnostics, Inc.
view all- K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
- K133751 — DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
- K124009 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
- K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
- K121040 — SMARTLYTE ELECTROLYTE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.