The following data is part of a premarket notification filed by Osborn Group, Inc. with the FDA for Hemochek Urine Collection Kit.
| Device ID | K991800 |
| 510k Number | K991800 |
| Device Name: | HEMOCHEK URINE COLLECTION KIT |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| 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 | JIQ |
| Subsequent Product Code | CGX |
| Subsequent Product Code | FMH |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-26 |
| Decision Date | 1999-09-24 |
| Summary: | summary |