HEART CHECK APOLIPOPROTEIN-B— 510(k) K881433

Substantially Equivalent

Northwest Biotech

FDA 510(k) clearance K881433 for HEART CHECK APOLIPOPROTEIN-B, Substantially Equivalent on 1988-04-21. Applicant: Northwest Biotech. Device class: 1.

Clearance details

Applicant
Northwest Biotech
Product code
Code MSJ
Device class
Class 1
Regulation
21 CFR 862.1475
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cottage Grove, OR, US
Download summary PDFView on FDA.gov ↗

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