The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop India Ink.
Device ID | K920976 |
510k Number | K920976 |
Device Name: | BACTIDROP INDIA INK |
Classification | Stains, Microbiologic |
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 | JTS |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-02 |
Decision Date | 1992-06-09 |