The following data is part of a premarket notification filed by Elan Diagnostics with the FDA for Atac Pak Alp Reagent Kit.
Device ID | K002285 |
510k Number | K002285 |
Device Name: | ATAC PAK ALP REAGENT KIT |
Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | ELAN DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
Contact | Wynn Stocking |
Correspondent | Wynn Stocking ELAN DIAGNOSTICS 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 | 2000-07-26 |
Decision Date | 2000-09-26 |