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

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..

Clearance details

Applicant: Oncogene Science, Inc.
Product code: Code NCW
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 ↗

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