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.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JHR
Device class: Class 2
Regulation: 21 CFR 866.5510
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 ↗

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More clearances from Boehringer Mannheim Corp.

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K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR1999-01-20
K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14
K984105 — ELECSYS TROPONIN T STAT TEST1998-12-08

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