FDA product code HYI: Iodine, Grams
HYI is the FDA product code for iodine, grams. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 6 510(k) submissions under HYI, from 6 different applicants. The average 510(k) review took 25 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Iodine, Grams |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HYI clearance
Top HYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 1 | 1987-04-08 |
| E K Ind., Inc. | 1 | 1984-08-10 |
| Granite Diagnostics, Inc. | 1 | 1982-07-22 |
| Meridian Diagnostics, Inc. | 1 | 1981-07-15 |
| Carr-Scarborough Microbiologicals, Inc. | 1 | 1979-10-17 |
1 more applicants have HYI clearances. See the full list in Caduvo.
Most recent HYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871286 | Remel Co. | GRAM IODINE | 1987-04-08 | 8 |
| K842733 | E K Ind., Inc. | GRAM IODINE | 1984-08-10 | 28 |
| K821977 | Granite Diagnostics, Inc. | GRAMSTAIN SET | 1982-07-22 | 16 |
| K811722 | Meridian Diagnostics, Inc. | PARA-PAK | 1981-07-15 | 27 |
| K791711 | Carr-Scarborough Microbiologicals, Inc. | IMPROVED GRAM STAIN REAGENTS | 1979-10-17 | 50 |
Recalls for HYI devices
openFDA lists no recalls for product code HYI.
Frequently asked questions
What is FDA product code HYI?
HYI is the FDA product code for iodine, grams. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYI?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYI?
Across 6 cleared submissions the average was 25 days from receipt to decision (median 24).
Which companies have the most HYI clearances?
Remel Co. (1); E K Ind., Inc. (1); Granite Diagnostics, Inc. (1); Meridian Diagnostics, Inc. (1); Carr-Scarborough Microbiologicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYI
- Run a recall and safety report across every HYI manufacturer
- Watch product code HYI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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