INNOFLUOR PHENYTOIN— 510(k) K841706

Substantially Equivalent

Innotron Diagnostics

FDA 510(k) clearance K841706 for INNOFLUOR PHENYTOIN, Substantially Equivalent on 1984-05-22. Applicant: Innotron Diagnostics. Device class: 2.

Clearance details

Applicant: Innotron Diagnostics
Product code: Code LGR
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1984-04-23
Decision date: 1984-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGR

K955873 — ACS PHENYTOIN ASSAY1996-03-11
K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM1996-01-24
K953840 — AXSYM PHENYTOIN II1995-09-25
K946328 — TDX(R)/TDXFLX(R) PHENYTOIN II1995-03-28
K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORS1994-10-27

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
K841707 — INNOFLUOR PHENOBARBITAL1984-05-23

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