The following data is part of a premarket notification filed by Elite Diagnostic Ltd. with the FDA for Edl One-stage Prothrombin Time Reagent.
| Device ID | K891370 |
| 510k Number | K891370 |
| Device Name: | EDL ONE-STAGE PROTHROMBIN TIME REAGENT |
| Classification | Test, Time, Prothrombin |
| Applicant | ELITE DIAGNOSTIC LTD. 3244 DOGWOOD CIRCLE SO. DR. Indianapolis, IN 46268 |
| Contact | Roy Speck |
| Correspondent | Roy Speck ELITE DIAGNOSTIC LTD. 3244 DOGWOOD CIRCLE SO. DR. Indianapolis, IN 46268 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-04-21 |