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

Hematoxylin Harris'S

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

HYK is the FDA product code for Hematoxylin Harris'S, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HYK
Device name
Hematoxylin Harris'S
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
7
Ingested recalls
0

Clearances, product code HYK

By decision year
7 clearances under product code HYK with a decision year between 1978 and 1987, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HYK by decision year
YearClearances
19781
19801
19811
19821
19841
19872

Applicants with the most clearances

Product code HYK
Applicants holding the most 510(k) clearances under product code HYK
ApplicantClearances
Accra Laboratories, Inc.2
Anatech, Ltd.1
Bioscientific1
Shandon, Inc.1
Surgipath1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order