The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Micro-albumin B/wako Micro Albumin Calibrator.
| Device ID | K944664 |
| 510k Number | K944664 |
| Device Name: | WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Tonya Mallory |
| Correspondent | Tonya Mallory WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | JIQ |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1995-02-07 |