The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Ostase Qc.
| Device ID | K994277 |
| 510k Number | K994277 |
| Device Name: | ACCESS OSTASE QC |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego, CA 92196 |
| Contact | Mara Caler |
| Correspondent | Mara Caler BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego, CA 92196 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-01-14 |
| Summary: | summary |