T-UPTAKE CALIBRATORS— 510(k) K951585

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K951585 for T-UPTAKE CALIBRATORS, Substantially Equivalent on 1995-06-15. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1995-04-06
Decision date: 1995-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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 Diagnostic Reagents, Inc.

K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY1998-11-18
K983812 — NAPA EIA ASSAY1998-11-16
K983323 — DIGOXIN IMMUNOASSAY1998-11-12
K983280 — VANCOMYCIN EIA ASSAY1998-11-06
K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS1998-11-05

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