EUROIMMUN ANTI-PLA2R IFA— 510(k) DEN140002

Unknown

Euroimmun US

FDA 510(k) clearance DEN140002 for EUROIMMUN ANTI-PLA2R IFA, Unknown on 2014-05-29. Applicant: Euroimmun US. Device class: 2.

Clearance details

Applicant: Euroimmun US
Product code: Code PGV
Device class: Class 2
Regulation: 21 CFR 866.5780
Advisory panel: Microbiology
Date received: 2014-03-28
Decision date: 2014-05-29
Decision: Unknown
Clearance type: Post-NSE
Location: Morris Plains, NJ, US

View on FDA.gov ↗

Recent devices under product code PGV

K132195 — EUROIMMUN ANTI-PLA2R ELISA (IGG)2014-06-27

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K131791 — IFA 40: HEP-20-102014-02-26
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Data sourced from openFDA. This site is unofficial and independent of the FDA.