The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access Hypersensitive Htsh Assay, Power Express Sample Processing System Generic Connection Module And Access Immunoassay System Reagents.
| Device ID | K140496 |
| 510k Number | K140496 |
| Device Name: | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive HTSH Assay, Power Express Sample Processing System Generic Connection Module And Access Immunoassay System Reagents |
| Classification | Radioassay, Vitamin B12 |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea, CA 92821 |
| Contact | Nanette Canepa |
| Correspondent | Nanette Canepa BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea, CA 92821 |
| Product Code | CDD |
| Subsequent Product Code | CGN |
| Subsequent Product Code | DBF |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590672324 | K140496 | 000 |