The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade Hepzyme.
| Device ID | K925452 |
| 510k Number | K925452 |
| Device Name: | DADE HEPZYME |
| Classification | Test, Heparin Neutralization |
| Applicant | BAXTER DIAGNOSTICS, INC. 1851 DELAWARE PKWY. Miami, FL 33125 |
| Contact | Charla Issitt |
| Correspondent | Charla Issitt BAXTER DIAGNOSTICS, INC. 1851 DELAWARE PKWY. Miami, FL 33125 |
| Product Code | JBR |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-28 |
| Decision Date | 1993-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768004049 | K925452 | 000 |
| 00842768019487 | K925452 | 000 |