INNOFLUOR THEOPHYLLINE— 510(k) K850629

Substantially Equivalent

Innotron Diagnostics

FDA 510(k) clearance K850629 for INNOFLUOR THEOPHYLLINE, Substantially Equivalent on 1985-03-12. Applicant: Innotron Diagnostics. Device class: 2.

Clearance details

Applicant: Innotron Diagnostics
Product code: Code LGS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1985-02-19
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Recent devices under product code LGS

K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)2007-06-08
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

More clearances from Innotron Diagnostics

K844721 — INNOFLUOR PRIMIDONE1985-01-08
K841865 — INNOFLOUR GENTAMICIN1984-05-31
K841866 — INNOFLOUR TOBRAMYCIN1984-05-31
K841707 — INNOFLUOR PHENOBARBITAL1984-05-23
K841706 — INNOFLUOR PHENYTOIN1984-05-22

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