The following data is part of a premarket notification filed by Elan Holdings, Inc. with the FDA for Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration Standards Kit.
| Device ID | K992845 |
| 510k Number | K992845 |
| Device Name: | HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-24 |
| Decision Date | 1999-10-18 |
| Summary: | summary |