LD-1— 510(k) K981338

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K981338 for LD-1, Substantially Equivalent on 1998-05-18. 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: 1998-04-13
Decision date: 1998-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGF

K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION1993-02-05
K914261 — ABBOTT QUICKSTART LD-1,#5A301991-10-21
K890996 — LD1 ISOENZYME REAGENT KIT1989-05-05
K871240 — ABBOTT A-GENT LD-1 ISOZYME REAGENT1987-05-13
K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)1986-04-11

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