The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp Prothrombin Time Test.
| Device ID | K880566 |
| 510k Number | K880566 |
| Device Name: | CLP PROTHROMBIN TIME TEST |
| Classification | Test, Time, Prothrombin |
| Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Contact | Roy Speck |
| Correspondent | Roy Speck CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL 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 | 1988-02-10 |
| Decision Date | 1988-03-23 |