The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Quantikine Ivd Beta-2-microglobulin Enzyme Immunoassay (eia(.
| Device ID | K964767 |
| 510k Number | K964767 |
| Device Name: | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-05-29 |
| Summary: | summary |