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

Hematoxylin Weigert'S

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

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

Classification record

Product code
HYO
Device name
Hematoxylin Weigert'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
1
Ingested recalls
0

Clearances, product code HYO

By decision year
1 clearance under product code HYO with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HYO by decision year
YearClearances
19831

Applicants with the most clearances

Product code HYO
Applicants holding the most 510(k) clearances under product code HYO
ApplicantClearances
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code