PROLYTE ELECTROLYTE ANALYZER— 510(k) K121140
Substantially EquivalentDiamond Diagnostics, Inc.
FDA 510(k) clearance K121140 for PROLYTE ELECTROLYTE ANALYZER, Substantially Equivalent on 2012-08-22. Applicant: Diamond Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Diamond Diagnostics, Inc.
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
Recent devices under product code JGS
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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
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.