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

Orange G

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

HZH is the FDA product code for Orange G, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HZH
Device name
Orange G
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
4
Ingested recalls
0

Clearances, product code HZH

By decision year
4 clearances under product code HZH with a decision year between 1980 and 1984, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HZH by decision year
YearClearances
19801
19811
19821
19841

Applicants with the most clearances

Product code HZH
Applicants holding the most 510(k) clearances under product code HZH
ApplicantClearances
Volu Sol Medical Industries2
E K Ind., Inc.1
Surgipath1

Companies listing this code with FDA

Companies whose registered establishments list this code