The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp Abnormal Coagulation Control.
| Device ID | K881510 |
| 510k Number | K881510 |
| Device Name: | CLP ABNORMAL COAGULATION CONTROL |
| Classification | Control, Plasma, Abnormal |
| 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 | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-05-06 |