MULTI-ANALYTE CHEMISTRY CALIBRATOR— 510(k) K070207

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K070207 for MULTI-ANALYTE CHEMISTRY CALIBRATOR, Substantially Equivalent on 2007-04-13. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant
Pointe Scientific, Inc.,
Product code
Code JIX
Device class
Class 2
Regulation
21 CFR 862.1150
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Lincoln Park, MI, US
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