ELECSYS CEA ASSAY— 510(k) K964368

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K964368 for ELECSYS CEA ASSAY, Substantially Equivalent on 1997-06-16. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1996-11-01
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.