DSL ESTRONE (DSL 8700)— 510(k) K935013
Substantially EquivalentDiagnostic Systems Laboratories, Inc.
FDA 510(k) clearance K935013 for DSL ESTRONE (DSL 8700), Substantially Equivalent on 1994-06-16. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Product code
- Code CGF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1280
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Webster, TX, US
Recent devices under product code CGF
view allMore clearances from Diagnostic Systems Laboratories, Inc.
view allRecalls naming K935013
K-number listed on FDA's recall record- Z-1369-2026 — Estrone RIA, REF: DSL8700
- Z-2152-2025 — Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- Z-2336-2025 — Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935013.
Data sourced from openFDA. This site is unofficial and independent of the FDA.