The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Abbott Prism Analyzer.
| Device ID | K940289 |
| 510k Number | K940289 |
| Device Name: | ABBOTT PRISM ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | ABBOTT MFG., INC. 1921 HURD DR. Irving, TX 75038 |
| Contact | Kathy Zeng |
| Correspondent | Kathy Zeng ABBOTT MFG., INC. 1921 HURD DR. Irving, TX 75038 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-02 |
| Decision Date | 1994-07-18 |