The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ferritin.
| Device ID | K971833 |
| 510k Number | K971833 |
| Device Name: | ELECSYS FERRITIN |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Leeann Chambers |
| Correspondent | Leeann Chambers BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-06-02 |
| Summary: | summary |