DSL DHEA (DSL 8900)— 510(k) K921534

Name: FDA 510(k) clearance K921534
Creator: U.S. Food and Drug Administration
Published: 1992-05-26

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K921534 for DSL DHEA (DSL 8900), Substantially Equivalent on 1992-05-26. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code JKL
Device class: Class 1
Regulation: 21 CFR 862.1060
Advisory panel: Clinical Chemistry
Date received: 1992-03-31
Decision date: 1992-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JKL

view all

K842310 — HEMATOLOGY ANALYZER1984-09-06

More clearances from Diagnostic Systems Laboratories, Inc.

view all

K061758 — ACTIVE RENIN IRMA2006-07-28
K020945 — AXSYM INTACT PTH, MODEL 2G062002-05-31
K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-85002002-03-01
K002128 — ACTIVE INHIBIN-A ELISA, MODEL DSL-10-281002000-12-05
K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-49002000-05-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.