A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM— 510(k) K882587

Clearance details

Applicant

A-Kem, Inc.

Product code

Code CIX

Device class

Class 2

Regulation

21 CFR 862.1035

Advisory panel

Clinical Chemistry

Date received

1988-06-23

Decision date

1988-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Clifton, NJ, US

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