The following data is part of a premarket notification filed by Pharmacia Eni Diagnostics, Inc. with the FDA for Gemtab System.
| Device ID | K894503 |
| 510k Number | K894503 |
| Device Name: | GEMTAB SYSTEM |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | PHARMACIA ENI DIAGNOSTICS, INC. 8310 GUILFORD RD. SUITE E Columbia, MD 21046 |
| Contact | Brandt |
| Correspondent | Brandt PHARMACIA ENI DIAGNOSTICS, INC. 8310 GUILFORD RD. SUITE E Columbia, MD 21046 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-09-05 |