The following data is part of a premarket notification filed by Microbiological Research Corp. with the FDA for The Golden Quad Test (hsv).
Device ID | K861120 |
510k Number | K861120 |
Device Name: | THE GOLDEN QUAD TEST (HSV) |
Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
Applicant | MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful, UT 84010 |
Contact | Carole A Golden |
Correspondent | Carole A Golden MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful, UT 84010 |
Product Code | GQO |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-25 |
Decision Date | 1987-02-02 |