ELECSYS IGE II IMMUNOASSAY— 510(k) K061970

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K061970 for ELECSYS IGE II IMMUNOASSAY, Substantially Equivalent on 2006-08-31. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JHR
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2006-07-12
Decision date: 2006-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHR

K984326 — ELECYS IGE ASSAY1999-02-08
K960067 — IMMILITE TOTAL IGE1996-02-14
K931703 — IMMULITE TOTAL IGE1993-08-16
K903000 — TURBO-RAST SPECIFIC IGE ASSAY1990-07-31
K901859 — COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE21990-05-03

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