The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Coaguchek System, Coaguchek System For Prothrombin Time Self Testing.
| Device ID | K974569 |
| 510k Number | K974569 |
| Device Name: | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Richard Naples |
| Correspondent | Richard Naples BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-08 |
| Decision Date | 1998-01-09 |