The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop(tm) Spot Indole.
Device ID | K913004 |
510k Number | K913004 |
Device Name: | BACTIDROP(TM) SPOT INDOLE |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
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 | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-08 |
Decision Date | 1991-09-18 |