The following data is part of a premarket notification filed by Osborn Group, Inc. with the FDA for Hemochek-a1c Sample Collection Kit.
| Device ID | K990899 |
| 510k Number | K990899 |
| Device Name: | HEMOCHEK-A1C SAMPLE COLLECTION KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | OSBORN GROUP, INC. 14901 WEST 117TH ST. Olathe, KS 66062 |
| Contact | Gilbert P Bourk Iii |
| Correspondent | Gilbert P Bourk Iii OSBORN GROUP, 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 | 1999-03-18 |
| Decision Date | 1999-12-21 |
| Summary: | summary |