The following data is part of a premarket notification filed by Flexsite Diagnostics, Inc. with the FDA for Urisite Urine Collection Kit For Microalbumin/creatinine Testing.
| Device ID | K001810 |
| 510k Number | K001810 |
| Device Name: | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-15 |
| Decision Date | 2000-08-14 |