The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Beta2 M-trac By Enzyme Bead-based Immunoassay Eia.
| Device ID | K895496 |
| 510k Number | K895496 |
| Device Name: | BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | John G Yager |
| Correspondent | John G Yager INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-09 |
| Decision Date | 1989-10-17 |