ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS— 510(k) K973583

Name: FDA 510(k) clearance K973583
Creator: U.S. Food and Drug Administration
Published: 1997-11-12

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K973583 for ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS, Substantially Equivalent on 1997-11-12. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1997-09-22
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLS

view all

K042520 — VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III2004-11-30
K042407 — EMIT CAFFEINE ASSAY2004-10-28
K020740 — ROCHE ONLINE THEOPHYLLINE2002-04-16
K011771 — RANDOX THEOPHYLLINE2002-01-17
K013272 — ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY2001-10-25

More clearances from Schiapparelli Biosystems, Inc.

view all

K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS1999-07-13
K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
K981377 — ACE T4 REAGENT T4 CALIBRATORS1998-06-10
K973581 — ACE VALPROIC ACID REAGENT, AED CALIBRATORS1997-11-12
K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS1997-11-12

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