ENZYMATIC TRIGLYCERIDE— 510(k) K810680

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K810680 for ENZYMATIC TRIGLYCERIDE, Substantially Equivalent on 1981-03-31. Applicant: Pointe Scientific, Inc.,. Device class: 1.

Clearance details

Applicant
Pointe Scientific, Inc.,
Product code
Code CDT
Device class
Class 1
Regulation
21 CFR 862.1705
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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