The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Instrinsic Factor Ab, Calibrators, And Qc On The Access Immunoassay Systems, Models 387992, 387993, 387999.
| Device ID | K033603 |
| 510k Number | K033603 |
| Device Name: | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 |
| Classification | Radioassay, Intrinsic Factor Blocking Antibody |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Valynda Machen |
| Correspondent | Valynda Machen BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LIG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-17 |
| Decision Date | 2003-12-19 |
| Summary: | summary |