The following data is part of a premarket notification filed by Columbia Bioscience, Inc. with the FDA for Cbi 7520 Reader.
| Device ID | K961183 |
| 510k Number | K961183 |
| Device Name: | CBI 7520 READER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | COLUMBIA BIOSCIENCE, INC. 182 THOMAS JOHSON DR. SUITE 205 Frederick, MD 21702 |
| Contact | Norman Jenkins |
| Correspondent | Norman Jenkins COLUMBIA BIOSCIENCE, INC. 182 THOMAS JOHSON DR. SUITE 205 Frederick, MD 21702 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-26 |
| Decision Date | 1996-08-02 |
| Summary: | summary |