FDA product code HYF: Giemsa Stain
HYF is the FDA product code for giemsa stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under HYF, from 3 different applicants. The average 510(k) review took 43 days (median 38). FDA has posted 1 recall for HYF devices.
Classification
| Field | Value |
|---|---|
| Device name | Giemsa Stain |
| 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 HYF clearance
Top HYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J.S. Medical Assoc. | 2 | 1983-11-25 |
| E K Ind., Inc. | 1 | 1984-08-15 |
| Case Instruments | 1 | 1983-06-08 |
Most recent HYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842742 | E K Ind., Inc. | GIEMSA STAIN | 1984-08-15 | 33 |
| K833665 | J.S. Medical Assoc. | HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK | 1983-11-25 | 38 |
| K833677 | J.S. Medical Assoc. | QUICK STAIN WRIGHT'S GIEMSA W/BUFF | 1983-11-25 | 38 |
| K831131 | Case Instruments | CASE WRIGHT-GIEMSA STAIN PAK | 1983-06-08 | 63 |
Recalls for HYF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code HYF?
HYF is the FDA product code for giemsa stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYF?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYF?
Across 4 cleared submissions the average was 43 days from receipt to decision (median 38).
Which companies have the most HYF clearances?
J.S. Medical Assoc. (2); E K Ind., Inc. (1); Case Instruments (1).
Have HYF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-03-15.
Next steps
- Run an FDA pathway report with predicate devices for product code HYF
- Run a recall and safety report across every HYF manufacturer
- Watch product code HYF 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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