The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Kd Activated Partial Thromboplastin Time Reagent.
| Device ID | K884485 |
| 510k Number | K884485 |
| Device Name: | KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Contact | Frances Loh |
| Correspondent | Frances Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1988-12-28 |