The following data is part of a premarket notification filed by Elan Holdings, Inc. with the FDA for Elan Alkaline Phosphate Reagent Kit.
| Device ID | K991387 |
| 510k Number | K991387 |
| Device Name: | ELAN ALKALINE PHOSPHATE REAGENT KIT |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Ralph Bolstad |
| Correspondent | Ralph Bolstad ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-05-19 |
| Summary: | summary |