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

Iodine, Grams

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

HYI is the FDA product code for Iodine, Grams, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HYI
Device name
Iodine, Grams
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
6
Ingested recalls
0

Clearances, product code HYI

By decision year
6 clearances under product code HYI with a decision year between 1978 and 1987, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HYI by decision year
YearClearances
19781
19791
19811
19821
19841
19871

Applicants with the most clearances

Product code HYI
Applicants holding the most 510(k) clearances under product code HYI
ApplicantClearances
Bioscientific1
Carr-Scarborough Microbiologicals, Inc.1
E K Ind., Inc.1
Granite Diagnostics, Inc.1
Meridian Diagnostics, Inc.1
Remel Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order