The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Act Test Catridges For Coaguchek Pro System, Act Controls For Coaguchek Pro System.
| Device ID | K992851 |
| 510k Number | K992851 |
| Device Name: | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-24 |
| Decision Date | 2000-01-14 |
| Summary: | summary |