ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)— 510(k) K070810

Name: FDA 510(k) clearance K070810
Creator: U.S. Food and Drug Administration
Published: 2007-06-08

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K070810 for ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F), Substantially Equivalent on 2007-06-08. Applicant: Biokit, S.A.. Device class: 2.

Clearance details

Applicant: Biokit, S.A.
Product code: Code LGS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 2007-03-26
Decision date: 2007-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGS

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K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM1996-01-24
K953016 — AXSYM THEOPHYLLINE II1995-08-24
K951169 — CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY1995-06-20
K942991 — QMS THEOPHYLLINE CS1994-09-09
K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II1993-08-09

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