ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752— 510(k) K013078

Clearance details

Applicant

Helena Laboratories

Product code

Code JBP

Device class

Class 2

Regulation

21 CFR 864.7140

Advisory panel

Hematology

Date received

2001-09-14

Decision date

2002-01-10

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 K013078.