The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ft3.
| Device ID | K963127 |
| 510k Number | K963127 |
| Device Name: | ELECSYS FT3 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Leeann Chambers, Rac |
| Correspondent | Leeann Chambers, Rac BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-12-16 |
| Summary: | summary |