The following data is part of a premarket notification filed by Bioassay Systems Research Corp. with the FDA for Hff Gencells.
| Device ID | K850990 |
| 510k Number | K850990 |
| Device Name: | HFF GENCELLS |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | BIOASSAY SYSTEMS RESEARCH CORP. 225 WILDWOOD AVE. Woburn, MA 01801 |
| Contact | Mark P Bear |
| Correspondent | Mark P Bear BIOASSAY SYSTEMS RESEARCH CORP. 225 WILDWOOD AVE. Woburn, MA 01801 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-04-12 |