The following data is part of a premarket notification filed by Elan Diagnostics with the FDA for Atac Pak Glucose Reagent And Atac Calibrator Kits.
| Device ID | K000556 |
| 510k Number | K000556 |
| Device Name: | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-18 |
| Decision Date | 2000-05-17 |