The following data is part of a premarket notification filed by Remel Co. with the FDA for Ef Synergy Quad Modified.
Device ID | K910242 |
510k Number | K910242 |
Device Name: | EF SYNERGY QUAD MODIFIED |
Classification | Manual Antimicrobial Susceptibility Test Systems |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | Ann Silvius |
Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Product Code | JWY |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-22 |
Decision Date | 1991-03-05 |