The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Advanced D-dimer.
| Device ID | K992957 |
| 510k Number | K992957 |
| Device Name: | ADVANCED D-DIMER |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-02 |
| Decision Date | 2000-01-28 |
| Summary: | summary |