DeviceClearance

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346— 510(k) K020625

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K020625 for SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346, Substantially Equivalent on 2002-05-06. Applicant: Helena Laboratories.

Clearance details

Applicant
Helena Laboratories
Product code
Code CIN
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaumont, TX, US
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