ABBOTT A-GENT LD-1 ISOZYME REAGENT— 510(k) K871240

Name: FDA 510(k) clearance K871240
Creator: U.S. Food and Drug Administration
Published: 1987-05-13

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K871240 for ABBOTT A-GENT LD-1 ISOZYME REAGENT, Substantially Equivalent on 1987-05-13. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JGF
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1987-03-27
Decision date: 1987-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGF

view all

K981338 — LD-11998-05-18
K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION1993-02-05
K914261 — ABBOTT QUICKSTART LD-1,#5A301991-10-21
K890996 — LD1 ISOENZYME REAGENT KIT1989-05-05
K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)1986-04-11

More clearances from Abbott Laboratories

view all

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.