The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Delfia Plate Fluorometer 1232.
| Device ID | K895240 |
| 510k Number | K895240 |
| Device Name: | DELFIA PLATE FLUOROMETER 1232 |
| Classification | Fluorometer, For Clinical Use |
| Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Contact | Albert P Mayo |
| Correspondent | Albert P Mayo PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-21 |
| Decision Date | 1989-10-04 |