The following data is part of a premarket notification filed by Osborn Group, Inc. with the FDA for Appraise Urine Microalbumin Collection Kit.
| Device ID | K002156 |
| 510k Number | K002156 |
| Device Name: | APPRAISE URINE MICROALBUMIN COLLECTION KIT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| 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 | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-12-19 |