ELECSYS DHEA-S CALSET— 510(k) K002760

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K002760 for ELECSYS DHEA-S CALSET, Substantially Equivalent on 2000-10-05. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2000-09-05
Decision date: 2000-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIS

K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR2012-08-14
K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR2006-05-31
K060266 — DIMENSION IRON CALIBRATOR2006-03-09
K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR2005-12-23
K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)2003-11-07

More clearances from Roche Diagnostics Corp.

K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2013-03-15
K101365 — ELECSYS CA 19-9 CALCHECK 52010-10-05
K100853 — COBAS 8000 MODULAR SERIES ANALYZER2010-09-09
K101196 — ACCU-CHEK ULTRFLEX INFUSION SET2010-08-27
K093664 — AMPHETAMINES II ASSAY2010-07-28

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