The following data is part of a premarket notification filed by Remel Co. with the FDA for Methanol, Absolute.
Device ID | K872189 |
510k Number | K872189 |
Device Name: | METHANOL, ABSOLUTE |
Classification | Stains, Microbiologic |
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 | JTS |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-07-29 |