HEP-TROL— 510(k) K801932

Clearance details

Applicant

Helena Laboratories

Product code

Code GGW

Device class

Class 2

Regulation

21 CFR 864.7925

Advisory panel

Hematology

Date received

1980-08-12

Decision date

1980-09-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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