DC-LINEATE CAT. NO. SE-091— 510(k) K932555

Name: FDA 510(k) clearance K932555
Creator: U.S. Food and Drug Administration
Published: 1993-08-19

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K932555 for DC-LINEATE CAT. NO. SE-091, Substantially Equivalent on 1993-08-19. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1993-05-26
Decision date: 1993-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIS

view all

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 Diagnostic Chemicals, Ltd. (Usa)

view all

K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-252002-08-23
K974874 — BILIRUBIN-SL (TOTAL) ASSAY1998-02-12
K932556 — AMMONIA ASSAY CAT. NO. 200-021994-08-02
K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)1993-12-10
K925877 — DC-UIBC-CAL1993-03-18

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