The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Cmv Igg Human Serum Controls.
Device ID | K951800 |
510k Number | K951800 |
Device Name: | CMV IGG HUMAN SERUM CONTROLS |
Classification | Antiserum, Cf, Cytomegalovirus |
Applicant | PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys, CA 91401 |
Contact | Jeanette R Porretta |
Correspondent | Jeanette R Porretta PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys, CA 91401 |
Product Code | GQI |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-18 |
Decision Date | 1995-11-16 |