The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Olympus Inorganic Phosphorus (2-reagent Modifica.).
| Device ID | K901807 |
| 510k Number | K901807 |
| Device Name: | OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-20 |
| Decision Date | 1990-05-02 |