The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Sysmex Automated Coagulation Analyzer, Model #ca-7000.
| Device ID | K020979 |
| 510k Number | K020979 |
| Device Name: | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 |
| Classification | Instrument, Coagulation, Automated |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-26 |
| Decision Date | 2002-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562205936 | K020979 | 000 |