The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Afp.
| Device ID | K973351 |
| 510k Number | K973351 |
| Device Name: | ELECSYS AFP |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-05 |
| Decision Date | 1997-11-21 |
| Summary: | summary |