EMIT DISOPYRAMIDE ASSAY— 510(k) K801204

Clearance details

Applicant

Syva Co.

Product code

Code KLR

Device class

Class 2

Regulation

21 CFR 862.3555

Advisory panel

Clinical Toxicology

Date received

1980-05-19

Decision date

1980-06-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K801204.