The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Hybritech P2psa Qc On The Access Immunoassay Systems.
| Device ID | K112603 |
| 510k Number | K112603 |
| Device Name: | ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Cindy Mcguire |
| Correspondent | Cindy Mcguire BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2011-11-04 |
| Summary: | summary |