The following data is part of a premarket notification filed by Remel Co. with the FDA for Tomtec Gram Stainer Decolorizer.
Device ID | K871533 |
510k Number | K871533 |
Device Name: | TOMTEC GRAM STAINER DECOLORIZER |
Classification | General Purpose Reagent |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | James G Baxendale |
Correspondent | James G Baxendale REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Product Code | PPM |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-20 |
Decision Date | 1987-04-29 |