The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Phosphorus Test (phos) Item Number 65416.
| Device ID | K945322 |
| 510k Number | K945322 |
| Device Name: | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | EMD CHEMICALS INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EMD CHEMICALS 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 | 1994-11-01 |
| Decision Date | 1994-12-07 |