The following data is part of a premarket notification filed by Mediatech, Inc. with the FDA for Penicillin/streptomycin Solution.
Device ID | K854567 |
510k Number | K854567 |
Device Name: | PENICILLIN/STREPTOMYCIN SOLUTION |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | MEDIATECH, INC. 13884 PARK CENTER RD. Herndon, VA 20171 |
Contact | Robert R Taschner |
Correspondent | Robert R Taschner MEDIATECH, INC. 13884 PARK CENTER RD. Herndon, VA 20171 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-14 |
Decision Date | 1985-12-06 |