PHOTOMETER, SEROMETER (MODEL 380)— 510(k) K760395

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K760395 for PHOTOMETER, SEROMETER (MODEL 380), Substantially Equivalent on 1976-11-01. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant
Mallinckrodt Critical Care
Product code
Code JJQ
Device class
Class 1
Regulation
21 CFR 862.2300
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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