The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Hybritech Psa Qc, Model 37209.
| Device ID | K994200 |
| 510k Number | K994200 |
| Device Name: | ACCESS HYBRITECH PSA QC, MODEL 37209 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Michele Gust |
| Correspondent | Michele Gust BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-13 |
| Decision Date | 2000-01-18 |
| Summary: | summary |