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

Eosin Y

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

HYB is the FDA product code for Eosin Y, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HYB
Device name
Eosin Y
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
10
Ingested recalls
3

Clearances, product code HYB

By decision year
10 clearances under product code HYB with a decision year between 1980 and 1989, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HYB by decision year
YearClearances
19801
19812
19823
19841
19882
19891

Applicants with the most clearances

Product code HYB
Applicants holding the most 510(k) clearances under product code HYB
ApplicantClearances
Sigma Chemical Co.3
Shandon, Inc.2
Accra Laboratories, Inc.1
EMD Millipore Corporation1
Richard-Allan Medical Ind., Inc.1
Surgipath1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order