CA BUFFER CA DYE— 510(k) K852002

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K852002 for CA BUFFER CA DYE, Substantially Equivalent on 1985-06-25. Applicant: Alpkem Corp.. Device class: 2.

Clearance details

Applicant
Alpkem Corp.
Product code
Code CIC
Device class
Class 2
Regulation
21 CFR 862.1145
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clackamas, OR, US
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