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

Hematoxylin

21 CFR 864.1850 / Hematology
FDA source (opens on fda.gov)

HYJ is the FDA product code for Hematoxylin, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HYJ
Device name
Hematoxylin
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
14
Ingested recalls
1

Clearances, product code HYJ

By decision year
14 clearances under product code HYJ with a decision year between 1981 and 1987, 1982 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HYJ by decision year
YearClearances
19813
19826
19831
19842
19872

Applicants with the most clearances

Product code HYJ
Applicants holding the most 510(k) clearances under product code HYJ
ApplicantClearances
Volu Sol Medical Industries3
Anatech, Ltd.2
E K Ind., Inc.2
Sigma Chemical Co.2
Surgipath2
Accra Laboratories, Inc.1
Fisher Scientific Company L.L.C.1
Richard-Allan Medical Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order