The following data is part of a premarket notification filed by Proteins Intl., Inc. with the FDA for Cytoquant Viral Transport Medium.
Device ID | K961756 |
510k Number | K961756 |
Device Name: | CYTOQUANT VIRAL TRANSPORT MEDIUM |
Classification | Culture Media, Propagating Transport |
Applicant | PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
Contact | Naomi Eliezer |
Correspondent | Naomi Eliezer PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
Product Code | JSN |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-06 |
Decision Date | 1996-05-17 |
Summary: | summary |