MG— 510(k) K981791

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K981791 for MG, Substantially Equivalent on 1998-10-23. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 1998-05-21
Decision date: 1998-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K981791

K-number listed on FDA's recall record

Z-0971-2019 — ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.Class II·Terminated·Abbott Laboratories, Inc·20190102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981791.

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