The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Reagent, Vdrl.
Device ID | K760098 |
510k Number | K760098 |
Device Name: | REAGENT, VDRL |
Classification | Antigens, Ha, Treponema Pallidum |
Applicant | GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GMT |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-14 |
Decision Date | 1976-08-03 |