The following data is part of a premarket notification filed by Genus Diagnostics with the FDA for Mrc-5 Gencells.
Device ID | K851562 |
510k Number | K851562 |
Device Name: | MRC-5 GENCELLS |
Classification | Cells, Animal And Human, Cultured |
Applicant | GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
Contact | Peter J Mionevenue |
Correspondent | Peter J Mionevenue GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
Product Code | KIR |
CFR Regulation Number | 864.2280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-16 |
Decision Date | 1985-05-10 |