BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT— 510(k) K934293

Substantially Equivalent

Beckman-Diagnostic Systems Group

FDA 510(k) clearance K934293 for BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT, Substantially Equivalent on 1994-07-06. Applicant: Beckman-Diagnostic Systems Group. Device class: 2.

Clearance details

Applicant
Beckman-Diagnostic Systems Group
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
Brea, CA, US
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