URIC ACID (LIQUID) REAGENT SET— 510(k) K970560

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K970560 for URIC ACID (LIQUID) REAGENT SET, Substantially Equivalent on 1997-03-11. Applicant: Pointe Scientific, Inc.,. Device class: 1.

Clearance details

Applicant
Pointe Scientific, Inc.,
Product code
Code KNK
Device class
Class 1
Regulation
21 CFR 862.1775
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lincoln Park, MI, US
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