The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Intelligent Photometers Mcp, Ifp, Isp, Fps, Sps.
| Device ID | K850392 |
| 510k Number | K850392 |
| Device Name: | INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-04-12 |