The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Kd 0.1 M Sodium Citrate Solution.
| Device ID | K883635 |
| 510k Number | K883635 |
| Device Name: | KD 0.1 M SODIUM CITRATE SOLUTION |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-25 |
| Decision Date | 1988-10-31 |