SPIFE IFE-6— 510(k) K973040

Clearance details

Applicant

Helena Laboratories

Product code

Code CFF

Device class

Class 2

Regulation

21 CFR 866.5510

Advisory panel

Immunology

Date received

1997-08-14

Decision date

1998-01-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beaumont, 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 K973040.