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

Immunohistochemistry Reagents And Kits

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

NJT is the FDA product code for Immunohistochemistry Reagents And Kits, a class I device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin". As of , FDA records hold no 510(k) clearances under this code and 92 recalls.

Classification record

Product code
NJT
Device name
Immunohistochemistry Reagents And Kits
FDA definition
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Regulation
21 CFR 864.1860
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
92

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order