The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Gleman Acd-2020 Automatic Computing Densitometer.
| Device ID | K850260 |
| 510k Number | K850260 |
| Device Name: | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Contact | Harwood Green |
| Correspondent | Harwood Green GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-02-27 |