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510(k) K994112

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) by Oncogene Science, Inc. — Product Code NCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2000
Date Received
December 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Her-2/Neu, Monitoring
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Oncogene Science, Inc.

  • K002121 — TOTAL PSA MICROTITER ELISA (August 30, 2000)
  • K002313 — COMPLEXED PSA MICROTITER ELISA (August 30, 2000)

Other clearances for product code NCW

  • K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY (January 30, 2003)
  • K992228 — BAYER IMMUNO 1 HER-2/NEU ASSAY (September 29, 2000)