The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Complement Control.
| Device ID | K960874 |
| 510k Number | K960874 |
| Device Name: | COMPLEMENT CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987481164659 | K960874 | 000 |