The following data is part of a premarket notification filed by Mediatech, Inc. with the FDA for Cellgro Hepes Buffer Solution.
| Device ID | K860623 |
| 510k Number | K860623 |
| Device Name: | CELLGRO HEPES BUFFER SOLUTION |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | MEDIATECH, INC. 13884 PARK CENTER RD. Herndon, VA 20171 |
| Contact | Robert Taschner |
| Correspondent | Robert 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 | 1986-02-19 |
| Decision Date | 1986-03-03 |