The following data is part of a premarket notification filed by Roche Diagnostics/boehringer Mannheim Gmbh with the FDA for Coaguchek Pro System, Aptt Test Cartridges For Coaguchek Pro System, Aptt Controls For Coaguchek Pro System, Coaguchek P.
| Device ID | K983892 |
| 510k Number | K983892 |
| Device Name: | COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 9115 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-03 |
| Decision Date | 1999-04-13 |
| Summary: | summary |