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

Peroxidase Anti-Peroxidase Immunohistochemical Stain

21 CFR 864.4400 / Pathology
FDA source (opens on fda.gov)

LIJ is the FDA product code for Peroxidase Anti-Peroxidase Immunohistochemical Stain, a class I device type, regulated under 21 CFR 864.4400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LIJ
Device name
Peroxidase Anti-Peroxidase Immunohistochemical Stain
Regulation
21 CFR 864.4400
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code LIJ

By decision year
2 clearances under product code LIJ with a decision year between 1982 and 1986, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LIJ by decision year
YearClearances
19821
19861

Applicants with the most clearances

Product code LIJ
Applicants holding the most 510(k) clearances under product code LIJ
ApplicantClearances
Bartels Immunodiagnostic Supplies, Inc.1
Dako Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code