The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade (pai-1) Chromogenic Assay Dade Coagtrol-pai.
| Device ID | K933188 |
| 510k Number | K933188 |
| Device Name: | DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-30 |
| Decision Date | 1993-09-22 |