The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Scott Selecticult-hsv Isolation &.
Device ID | K841680 |
510k Number | K841680 |
Device Name: | SCOTT SELECTICULT-HSV ISOLATION & |
Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
Applicant | SCOTT LABORATORIES, INC. Fiskeville , RI 02823 - |
Contact | Thomas W Kelley |
Correspondent | Thomas W Kelley SCOTT LABORATORIES, INC. Fiskeville , RI 02823 - |
Product Code | GQL |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-10-30 |