The following data is part of a premarket notification filed by Elan Pharma, Inc. with the FDA for Hichem Phosphorus Reagent Kit.
| Device ID | K981769 |
| 510k Number | K981769 |
| Device Name: | HICHEM PHOSPHORUS REAGENT KIT |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | ELAN PHARMA, INC. 231 NORTH PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN PHARMA, INC. 231 NORTH PUENTE ST. Brea, CA 92621 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-06-29 |
| Summary: | summary |