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

Control Material, Her-2/Neu, Immunohistochemistry

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

NJW is the FDA product code for Control Material, Her-2/Neu, Immunohistochemistry, a class II device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NJW
Device name
Control Material, Her-2/Neu, Immunohistochemistry
FDA definition
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code NJW

By decision year
2 clearances under product code NJW with a decision year between 2003 and 2022, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NJW by decision year
YearClearances
20031
20221

Applicants with the most clearances

Product code NJW
Applicants holding the most 510(k) clearances under product code NJW
ApplicantClearances
Boston Cell Standards Inc1
Qc Sciences, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code