The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Direct Ldl-c.
| Device ID | K982271 |
| 510k Number | K982271 |
| Device Name: | WAKO DIRECT LDL-C |
| Classification | System, Test, Low Density, Lipoprotein |
| 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 | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1998-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987481164543 | K982271 | 000 |
| 04987481164536 | K982271 | 000 |