The following data is part of a premarket notification filed by Osborn Laboratories, Inc. with the FDA for Hemochek Sample Collection Kit.
| Device ID | K984529 |
| 510k Number | K984529 |
| Device Name: | HEMOCHEK SAMPLE COLLECTION KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | OSBORN LABORATORIES, INC. 14901 WEST 117TH ST. Olathe, KS 66062 |
| Contact | Gilbert P Bourke Iii |
| Correspondent | Gilbert P Bourke Iii OSBORN LABORATORIES, INC. 14901 WEST 117TH ST. Olathe, KS 66062 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-01-28 |
| Summary: | summary |