INNOFLUOR PHENOBARBITAL— 510(k) K841707

Substantially Equivalent

Innotron Diagnostics

FDA 510(k) clearance K841707 for INNOFLUOR PHENOBARBITAL, Substantially Equivalent on 1984-05-23. Applicant: Innotron Diagnostics. Device class: 2.

Clearance details

Applicant: Innotron Diagnostics
Product code: Code LGQ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1984-04-23
Decision date: 1984-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGQ

K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM1997-08-01
K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM1997-07-14
K940596 — AXSYM PHENOBARBITAL1994-06-21
K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS1994-03-11
K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA1990-04-12

More clearances from Innotron Diagnostics

K850629 — INNOFLUOR THEOPHYLLINE1985-03-12
K844721 — INNOFLUOR PRIMIDONE1985-01-08
K841865 — INNOFLOUR GENTAMICIN1984-05-31
K841866 — INNOFLOUR TOBRAMYCIN1984-05-31
K841706 — INNOFLUOR PHENYTOIN1984-05-22

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