MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)— 510(k) K994112

Name: FDA 510(k) clearance K994112
Creator: U.S. Food and Drug Administration
Published: 2000-09-29

Substantially Equivalent

Oncogene Science, Inc.

FDA 510(k) clearance K994112 for MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA), Substantially Equivalent on 2000-09-29. Applicant: Oncogene Science, Inc.. Device class: 2.

Clearance details

Applicant: Oncogene Science, Inc.
Product code: Code NCW
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1999-12-06
Decision date: 2000-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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