PARAMAX AMMONIA AND AMMONIA BLANK REAGENT— 510(k) K964565

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K964565 for PARAMAX AMMONIA AND AMMONIA BLANK REAGENT, Substantially Equivalent on 1996-11-22. Applicant: Dade Intl., Inc.. Device class: 1.

Clearance details

Applicant
Dade Intl., Inc.
Product code
Code JIF
Device class
Class 1
Regulation
21 CFR 862.1065
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
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