BIOSTRIP G— 510(k) K820594

Clearance details

Applicant

Helena Laboratories

Product code

Code JIL

Device class

Class 2

Regulation

21 CFR 862.1340

Advisory panel

Clinical Chemistry

Date received

1982-03-04

Decision date

1982-05-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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