510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994112Substantially Equivalent

Manual Her-2/Neu Microtiter Elisa (Osdi Her-2/Neu Elisa)

Oncogene Science, Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994112 is the FDA 510(k) clearance record for MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA), a class II device, cleared for Oncogene Science, Inc. on under FDA product code NCW (System, Test, Her-2/Neu, Monitoring). FDA records list 3 510(k) clearances for Oncogene Science, Inc., from to . As of , FDA records show no recalls naming K994112.

Clearance record

Decision date
Received
(298 days to decision)
Product code
NCW System, Test, Her-2/Neu, Monitoring
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Oncogene Science, Inc. 80 Rogers St., Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code NCW

Trailing 12 months

FDA records hold no clearances under product code NCW in the trailing twelve months.

FDA records show no clearances under product code NCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260