AXSYM PHENOBARBITAL— 510(k) K940596

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K940596 for AXSYM PHENOBARBITAL, Substantially Equivalent on 1994-06-21. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LGQ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1994-02-10
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spartanburg, SC, 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
K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS1994-03-11
K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA1990-04-12
K894525 — FPR PHENOBARBITAL KIT1989-08-28

More clearances from Abbott Laboratories

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

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