PHOS— 510(k) K981759

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K981759 for PHOS, Substantially Equivalent on 1998-06-16. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1998-05-19
Decision date: 1998-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K981759

K-number listed on FDA's recall record

Z-0020-2014 — Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.Class II·Terminated·Abbott Laboratories, Inc·20130812

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981759.

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