The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp Glycosylated Hemoglobin Control-er.
| Device ID | K896334 |
| 510k Number | K896334 |
| Device Name: | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Contact | Proksch, Phd |
| Correspondent | Proksch, Phd CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-03 |
| Decision Date | 1989-12-11 |