The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Direct Hdl-c.
| Device ID | K963847 |
| 510k Number | K963847 |
| Device Name: | WAKO DIRECT HDL-C |
| Classification | Calibrator, Primary |
| 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 | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1996-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856626006196 | K963847 | 000 |
| 10856626006141 | K963847 | 000 |
| 10856626006097 | K963847 | 000 |
| 10856626006042 | K963847 | 000 |
| 04987481164598 | K963847 | 000 |
| 04987481164581 | K963847 | 000 |
| 04987481164574 | K963847 | 000 |
| 04987481164567 | K963847 | 000 |