DIGOXIN & PHENYTOIN CONTROL SERA— 510(k) K803097

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K803097 for DIGOXIN & PHENYTOIN CONTROL SERA, Substantially Equivalent on 1980-12-22. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant
Amersham Corp.
Product code
Code DIF
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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