The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Total Iron And Unsat Iron Bind Capac/iron Bind Cal.
| Device ID | K913371 |
| 510k Number | K913371 |
| Device Name: | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL |
| Classification | Calibrator, Secondary |
| Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Contact | Gary J Proksch |
| Correspondent | Gary J Proksch CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-11-08 |