510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HZZClass I

Sudan Black B

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

HZZ is the FDA product code for Sudan Black B, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HZZ
Device name
Sudan Black B
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
2
Ingested recalls
0

Clearances, product code HZZ

By decision year
2 clearances under product code HZZ with a decision year between 1979 and 1984, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HZZ by decision year
YearClearances
19791
19841

Applicants with the most clearances

Product code HZZ
Applicants holding the most 510(k) clearances under product code HZZ
ApplicantClearances
Electrophoresis Corp. of America1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code