FDA product code KES: Coverslips, Microscope Slide
KES is the FDA product code for coverslips, microscope slide. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under KES, from 3 different applicants. The average 510(k) review took 19 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Coverslips, Microscope Slide |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top KES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sakura Finetek U.S.A., Inc. | 1 | 1988-07-28 |
| Abco Dealers, Inc. | 1 | 1987-08-10 |
| Harleco | 1 | 1977-11-02 |
Most recent KES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882881 | Sakura Finetek U.S.A., Inc. | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | 1988-07-28 | 17 |
| K872874 | Abco Dealers, Inc. | MICROSCOPE COVER GLASSES | 1987-08-10 | 20 |
| K771925 | Harleco | KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP | 1977-11-02 | 19 |
Recalls for KES devices
openFDA lists no recalls for product code KES.
Frequently asked questions
What is FDA product code KES?
KES is the FDA product code for coverslips, microscope slide. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KES?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KES?
Across 3 cleared submissions the average was 19 days from receipt to decision (median 19).
Which companies have the most KES clearances?
Sakura Finetek U.S.A., Inc. (1); Abco Dealers, Inc. (1); Harleco (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KES
- Run a recall and safety report across every KES manufacturer
- Watch product code KES 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.