FDA product code IAF: Wright'S Stain
IAF is the FDA product code for wright's stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 33 510(k) submissions under IAF, from 19 different applicants. The average 510(k) review took 36 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Wright'S 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 IAF clearance
Top IAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accra Laboratories, Inc. | 6 | 1983-03-17 |
| Mcb Manufacturing Chemists, Inc. | 3 | 1980-05-30 |
| Sigma Diagnostics, Inc. | 2 | 1989-02-24 |
| Cambridge Chemical Products, Inc. | 2 | 1986-03-18 |
| E K Ind., Inc. | 2 | 1984-08-12 |
14 more applicants have IAF clearances. See the full list in Caduvo.
Most recent IAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890674 | Sigma Diagnostics, Inc. | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET | 1989-02-24 | 15 |
| K890673 | Sigma Diagnostics, Inc. | WRIGHT-GLEMSA STAIN | 1989-02-24 | 15 |
| K854236 | Nms Pharmaceuticals, Inc. | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | 1986-10-10 | 354 |
| K860793 | Cambridge Chemical Products, Inc. | CAMCO STAIN PAK | 1986-03-18 | 14 |
| K853241 | Fisher Scientific Co., LLC | HEMATOLOGY STAIN PACK | 1985-08-19 | 18 |
Recalls for IAF devices
openFDA lists no recalls for product code IAF.
Frequently asked questions
What is FDA product code IAF?
IAF is the FDA product code for wright's stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IAF?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IAF?
Across 33 cleared submissions the average was 36 days from receipt to decision (median 22).
Which companies have the most IAF clearances?
Accra Laboratories, Inc. (6); Mcb Manufacturing Chemists, Inc. (3); Sigma Diagnostics, Inc. (2); Cambridge Chemical Products, Inc. (2); E K Ind., Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code IAF
- Run a recall and safety report across every IAF manufacturer
- Watch product code IAF 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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