The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Rubeola Test.
Device ID | K884004 |
510k Number | K884004 |
Device Name: | RUBEOLA TEST |
Classification | Antiserum, Fluorescent, Rubeola |
Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
Contact | Rachford, Phd |
Correspondent | Rachford, Phd GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
Product Code | GRE |
CFR Regulation Number | 866.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-21 |
Decision Date | 1988-12-05 |