The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Ostase Immunoenzymetric Assay.
| Device ID | K994278 |
| 510k Number | K994278 |
| Device Name: | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego, CA 92196 |
| Contact | Jill Kull |
| Correspondent | Jill Kull BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego, CA 92196 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590677381 | K994278 | 000 |
| 15099590232313 | K994278 | 000 |