The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Coaguchek Pst System.
| Device ID | K962571 |
| 510k Number | K962571 |
| Device Name: | COAGUCHEK PST SYSTEM |
| Classification | Test, Time, Prothrombin |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Michael Flis |
| Correspondent | Michael Flis BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1997-04-22 |
| Summary: | summary |