The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp 0.02 M Calcium Chloride Solution..
| Device ID | K880711 |
| 510k Number | K880711 |
| Device Name: | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. |
| Classification | Reagent & Control, Partial Thromboplastin Time |
| 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 | GIT |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-03-18 |