The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Hdl-c/ldl-c Calibrator.
| Device ID | K001005 |
| 510k Number | K001005 |
| Device Name: | WAKO HDL-C/LDL-C CALIBRATOR |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-29 |
| Decision Date | 2000-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856626006035 | K001005 | 000 |
| 04987481164550 | K001005 | 000 |