The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ige Calcheck.
| Device ID | K984419 |
| 510k Number | K984419 |
| Device Name: | ELECSYS IGE CALCHECK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-10 |
| Decision Date | 1999-02-02 |
| Summary: | summary |