DSL ACTIVE ALDOSTERONE (DSL 8600)— 510(k) K921205
Substantially EquivalentDiagnostic Systems Laboratories, Inc.
FDA 510(k) clearance K921205 for DSL ACTIVE ALDOSTERONE (DSL 8600), Substantially Equivalent on 1992-07-10. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Product code
- Code CJM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1045
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Webster, TX, US
Recent devices under product code CJM
view all- K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
- K130321 — LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
- K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K943397 — DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
More clearances from Diagnostic Systems Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.