The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Dade Factor Viii Chromogenic Assay.
| Device ID | K884544 |
| 510k Number | K884544 |
| Device Name: | DADE FACTOR VIII CHROMOGENIC ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Jeanne-marie Varga |
| Correspondent | Jeanne-marie Varga BAXTER HEALTHCARE CORP. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-31 |
| Decision Date | 1988-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768004032 | K884544 | 000 |
| 00630414640389 | K884544 | 000 |