REP(TM) CK-2 STAT KIT, CAT. NO. 3074— 510(k) K893007

Clearance details

Applicant

Helena Laboratories

Product code

Code CGS

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1989-04-24

Decision date

1989-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beaumont, TX, US

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