The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control Set.
| Device ID | K030320 |
| 510k Number | K030320 |
| Device Name: | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET |
| Classification | Calibrator, Primary |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Lori Creasy |
| Correspondent | Lori Creasy WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | JIS |
| Subsequent Product Code | JIQ |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-30 |
| Decision Date | 2003-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740003654 | K030320 | 000 |
| 00380740003647 | K030320 | 000 |
| 00380740003630 | K030320 | 000 |
| 00856626006106 | K030320 | 000 |
| 04987481164529 | K030320 | 000 |
| 04987481164673 | K030320 | 000 |
| 04987481164666 | K030320 | 000 |