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FDA 510(k)

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

K-Number: K994112 · 2000-09-29

ApplicantOncogene Science, Inc.
Decision Date2000-09-29
Product CodeNCW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) is the device name listed in this FDA 510(k) record. The listed applicant is Oncogene Science, Inc.. It received FDA 510(k) clearance on 2000-09-29 under 510(k) number K994112. The device is classified under product code NCW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)?

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) is a medical device that received FDA 510(k) clearance on 2000-09-29. The listed applicant is Oncogene Science, Inc.. The 510(k) number is K994112.

When did MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) receive FDA 510(k) clearance?

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) received FDA 510(k) clearance on 2000-09-29, under 510(k) number K994112.

Who is the listed applicant for MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)?

The FDA 510(k) record lists Oncogene Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)?

The FDA product code for MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) is NCW.

Related Clinical Trials

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Other records listing Oncogene Science, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002313COMPLEXED PSA MICROTITER ELISAK002121TOTAL PSA MICROTITER ELISA

Related Devices (Code: NCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYBayer Corp.K992228BAYER IMMUNO 1 HER-2/NEU ASSAYBayer Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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