The following data is part of a premarket notification filed by Viratest Intl., Inc. with the FDA for A549 Cell Culture.
Device ID | K955921 |
510k Number | K955921 |
Device Name: | A549 CELL CULTURE |
Classification | Cells, Animal And Human, Cultured |
Applicant | VIRATEST INTL., INC. 7540 LOUIS PASTEUR, SUITE 205 San Antonio, TX 78229 |
Contact | William J Northam |
Correspondent | William J Northam VIRATEST INTL., INC. 7540 LOUIS PASTEUR, SUITE 205 San Antonio, TX 78229 |
Product Code | KIR |
CFR Regulation Number | 864.2280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-14 |
Decision Date | 1996-02-16 |