FDA product code HYB: Eosin Y
HYB is the FDA product code for eosin y. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 10 510(k) submissions under HYB, from 7 different applicants. The average 510(k) review took 25 days (median 21). FDA has posted 3 recalls for HYB devices.
Classification
| Field | Value |
|---|---|
| Device name | Eosin Y |
| 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 HYB clearance
Top HYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 3 | 1988-03-31 |
| Shandon, Inc. | 2 | 1989-06-13 |
| Accra Laboratories, Inc. | 1 | 1984-09-27 |
| Emd Chemicals, Inc. | 1 | 1982-10-27 |
| Richard-Allan Medical Ind., Inc. | 1 | 1981-07-28 |
2 more applicants have HYB clearances. See the full list in Caduvo.
Most recent HYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893663 | Shandon, Inc. | INSTANT EOSIN-AQUEOUS | 1989-06-13 | 29 |
| K880596 | Sigma Chemical Co. | EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE | 1988-03-31 | 49 |
| K880240 | Shandon, Inc. | INSTANT EOSIN-ALCOHOLIC | 1988-03-03 | 43 |
| K843426 | Accra Laboratories, Inc. | EOSIN Y 1% ALCOHOLIC | 1984-09-27 | 23 |
| K822982 | Emd Chemicals, Inc. | MIDAS 100 HEMACOLOR STAIN #66030 | 1982-10-27 | 19 |
Recalls for HYB devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-01-06.
Frequently asked questions
What is FDA product code HYB?
HYB is the FDA product code for eosin y. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYB?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYB?
Across 10 cleared submissions the average was 25 days from receipt to decision (median 21).
Which companies have the most HYB clearances?
Sigma Chemical Co. (3); Shandon, Inc. (2); Accra Laboratories, Inc. (1); Emd Chemicals, Inc. (1); Richard-Allan Medical Ind., Inc. (1).
Have HYB devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2010-01-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HYB
- Run a recall and safety report across every HYB manufacturer
- Watch product code HYB 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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