FDA product code KEW: Slides, Microscope
KEW is the FDA product code for slides, microscope. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 8 510(k) submissions under KEW, from 7 different applicants. The average 510(k) review took 36 days (median 27). FDA has posted 1 recall for KEW devices.
Classification
| Field | Value |
|---|---|
| Device name | Slides, Microscope |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KEW clearance
Top KEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stat Path | 2 | 1989-01-13 |
| Davstar California, Inc. | 1 | 1989-06-16 |
| Technicon Instruments Corp. | 1 | 1983-06-08 |
| Stan-Pak Ent. | 1 | 1982-03-04 |
| Kallestad Laboratories, Inc. | 1 | 1981-12-02 |
2 more applicants have KEW clearances. See the full list in Caduvo.
Most recent KEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891604 | Davstar California, Inc. | THE CEN-SLIDE(TM) CENTRIFUGE TUBE | 1989-06-16 | 88 |
| K890042 | Stat Path | MICROSCOPE SLIDES PRECOATED | 1989-01-13 | 8 |
| K882357 | Stat Path | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | 1988-06-16 | 9 |
| K831065 | Technicon Instruments Corp. | SECTIONING AID KIT | 1983-06-08 | 65 |
| K820100 | Stan-Pak Ent. | FROSTED GLASS SLIDES | 1982-03-04 | 50 |
Recalls for KEW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-01-29.
Frequently asked questions
What is FDA product code KEW?
KEW is the FDA product code for slides, microscope. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KEW?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEW?
Across 8 cleared submissions the average was 36 days from receipt to decision (median 27).
Which companies have the most KEW clearances?
Stat Path (2); Davstar California, Inc. (1); Technicon Instruments Corp. (1); Stan-Pak Ent. (1); Kallestad Laboratories, Inc. (1).
Have KEW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code KEW
- Run a recall and safety report across every KEW manufacturer
- Watch product code KEW 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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