The following data is part of a premarket notification filed by General Diagnostics with the FDA for Verify S Prod. #34141.
| Device ID | K800925 |
| 510k Number | K800925 |
| Device Name: | VERIFY S PROD. #34141 |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-07-21 |