ELECYS IGE ASSAY— 510(k) K984326

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K984326 for ELECYS IGE ASSAY, Substantially Equivalent on 1999-02-08. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JHR
Advisory panel: Immunology
Date received: 1998-12-03
Decision date: 1999-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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