The following data is part of a premarket notification filed by Artel, Inc. with the FDA for Artel Differential Photometer.
| Device ID | K864542 |
| 510k Number | K864542 |
| Device Name: | ARTEL DIFFERENTIAL PHOTOMETER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ARTEL, INC. 28 DEPOT ST. South Windham, MA 04082 |
| Contact | Kirby B Pilcher |
| Correspondent | Kirby B Pilcher ARTEL, INC. 28 DEPOT ST. South Windham, MA 04082 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-19 |
| Decision Date | 1987-02-06 |