FDA product code KQC: Stains, Hematology
KQC is the FDA product code for stains, hematology. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 9 510(k) submissions under KQC, from 7 different applicants. The average 510(k) review took 35 days (median 37). FDA has posted 5 recalls for KQC devices.
Classification
| Field | Value |
|---|---|
| Device name | Stains, Hematology |
| 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 KQC clearance
Top KQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R&D Systems, Inc. | 2 | 1984-10-30 |
| Geometric Data, Div. Smithkline Corp. | 2 | 1976-08-30 |
| Anatech, Ltd. | 1 | 1988-07-28 |
| Warner-Lambert Co. | 1 | 1985-08-13 |
| Electrophoresis Corp. of America | 1 | 1980-01-16 |
2 more applicants have KQC clearances. See the full list in Caduvo.
Most recent KQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882873 | Anatech, Ltd. | FIELDTEX HEMATOXYLIN | 1988-07-28 | 17 |
| K852843 | Warner-Lambert Co. | GENERAL DIAGNOSTICS COAG-A-MATE XC | 1985-08-13 | 39 |
| K843619 | R&D Systems, Inc. | RETIC-SET | 1984-10-30 | 46 |
| K841848 | R&D Systems, Inc. | RETIC-SET | 1984-05-31 | 64 |
| K792550 | Electrophoresis Corp. of America | PONCEAU S STAIN SET | 1980-01-16 | 37 |
Recalls for KQC devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code KQC?
KQC is the FDA product code for stains, hematology. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KQC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQC?
Across 9 cleared submissions the average was 35 days from receipt to decision (median 37).
Which companies have the most KQC clearances?
R&D Systems, Inc. (2); Geometric Data, Div. Smithkline Corp. (2); Anatech, Ltd. (1); Warner-Lambert Co. (1); Electrophoresis Corp. of America (1).
Have KQC devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2018-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KQC
- Run a recall and safety report across every KQC manufacturer
- Watch product code KQC 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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