SPECTRO-SUR SET— 510(k) K791315

Clearance details

Applicant

Helena Laboratories

Product code

Code JIS

Device class

Class 2

Regulation

21 CFR 862.1150

Advisory panel

Clinical Chemistry

Date received

1979-07-16

Decision date

1979-08-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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