The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Ch50.
| Device ID | K954145 |
| 510k Number | K954145 |
| Device Name: | WAKO AUTOKIT CH50 |
| Classification | Complement C9, Antigen, Antiserum, Control |
| 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 | DAE |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856626006151 | K954145 | 000 |
| 00856626006113 | K954145 | 000 |
| 04987481164512 | K954145 | 000 |
| 00498748116440 | K954145 | 000 |