ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS; MODELS 1E08 AND 5F54— 510(k) K993031

Clearance details

Device name as filed

ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54

Applicant

Syva Co.

Product code

Code DLZ

Device class

Class 2

Regulation

21 CFR 862.3660

Advisory panel

Clinical Toxicology

Date received

1999-09-09

Decision date

2000-01-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993031.