AEROSET SYSTEM— 510(k) K980367

Clearance details

Applicant

Abbott Laboratories

Product code

Code CGZ

Device class

Class 2

Regulation

21 CFR 862.1170

Advisory panel

Clinical Chemistry

Date received

1998-01-29

Decision date

1998-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irving, TX, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980367.