AST REAGENT CARTRIDGE— 510(k) K861283

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K861283 for AST REAGENT CARTRIDGE, Substantially Equivalent on 1986-04-28. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant
Hi Chem, Inc.
Product code
Code CIT
Device class
Class 2
Regulation
21 CFR 862.1100
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
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