The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade(r) Alpha 2 Antiplasmin(2 2-ap) Chromo Assay.
| Device ID | K914818 |
| 510k Number | K914818 |
| Device Name: | DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Nancy A Hornbaker |
| Correspondent | Nancy A Hornbaker BAXTER DIAGNOSTICS, INC. 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 | 1991-10-25 |
| Decision Date | 1992-01-15 |