KESClass I
Coverslips, Microscope Slide
21 CFR 864.3010 / Pathology
KES is the FDA product code for Coverslips, Microscope Slide, a class I device type, regulated under 21 CFR 864.3010. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KES
- Device name
- Coverslips, Microscope Slide
- Regulation
- 21 CFR 864.3010
- Device class
- Class I
- Review panel
- Pathology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code KES
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1987 | 1 |
| 1988 | 1 |
Applicants with the most clearances
Product code KES| Applicant | Clearances |
|---|---|
| Abco Dealers, Inc. | 1 |
| Harleco | 1 |
| Sakura Finetek USA Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accuster Technologies Pvt. Ltd.
- Agilent Technologies Denmark ApS
- Agilent Technologies Singapore (International) Pte Ltd.
- Agilent Technologies, Inc.
- Anji Spenq Industrial Co., Ltd.
- Apothecaries Sundries Mfg Pvt Ltd
- ATSI Logistics Center ApS
- Azer Scientific, Inc.
- Belair Instrument Co, LLC D/B/a Avantik
- Biocare Medical LLC
- Biomed Plastics Co.
- Biosys Laboratories, Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
