HICHEM LDH/L REAGENT KIT— 510(k) K946022

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K946022 for HICHEM LDH/L REAGENT KIT, Substantially Equivalent on 1995-02-23. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant
Hichem Diagnostics
Product code
Code CFJ
Device class
Class 2
Regulation
21 CFR 862.1440
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
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