The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Rf.
Device ID | K922151 |
510k Number | K922151 |
Device Name: | WAKO AUTOKIT RF |
Classification | System, Test, Rheumatoid Factor |
Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
Contact | Edward Zior |
Correspondent | Edward Zior WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-07 |
Decision Date | 1992-07-28 |