CARESIDE AMYLASE— 510(k) K990025

Substantially Equivalent

Careside, Inc.

FDA 510(k) clearance K990025 for CARESIDE AMYLASE, Substantially Equivalent on 1999-02-08. Applicant: Careside, Inc.. Device class: 2.

Clearance details

Applicant
Careside, Inc.
Product code
Code JFJ
Device class
Class 2
Regulation
21 CFR 862.1070
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Culver City, CA, US
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