The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Nefa Linearity Set.
Device ID | K030065 |
510k Number | K030065 |
Device Name: | WAKO NEFA LINEARITY SET |
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 | 2003-01-07 |
Decision Date | 2003-02-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987481164642 | K030065 | 000 |