Manual HER-2/NEU Microtiter Elisa (Osdi HER-2/NEU Elisa)

FDA 510(k) K994112 · Oncogene Science, Inc.

Substantially Equivalent

510(k) numberK994112

Submission

Device name
Manual HER-2/NEU Microtiter Elisa (Osdi HER-2/NEU Elisa)
Applicant
Oncogene Science, Inc.
Cambridge, MA, US
Received
December 6, 1999
Decision date
September 29, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NCW – System, Test, Her-2/Neu, Monitoring
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Specialty
Immunology

Other 510(k)s with product code NCW

510(k)DeviceApplicantDecision
K024017Bayer Advia Centaur HER-2/NEU AssayNCW · Traditional Bayer Corp.01/30/2003SE
K992228Bayer Immuno 1 HER-2/NEU AssayNCW · Traditional Bayer Corp.09/29/2000SE

More from Bayer Corp.

510(k)DeviceDecision
K002313Complexed Psa Microtiter ElisaLTJ · Traditional 08/30/2000SE
K002121Total Psa Microtiter ElisaLTJ · Traditional 08/30/2000SE

Questions and answers

When was Manual HER-2/NEU Microtiter Elisa (Osdi HER-2/NEU Elisa) cleared by the FDA?

Manual HER-2/NEU Microtiter Elisa (Osdi HER-2/NEU Elisa) (K994112) received a 510(k) decision of Substantially Equivalent on September 29, 2000, 298 days after the submission was received.

What is the product code of K994112?

The FDA product code is NCW – System, Test, Her-2/Neu, Monitoring, a Class II (moderate risk) device regulated under 21 CFR 866.6010.