The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Tsh Assay.
| Device ID | K961491 |
| 510k Number | K961491 |
| Device Name: | ELECSYS TSH ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-maddox BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-18 |
| Decision Date | 1996-07-22 |
| Summary: | summary |