The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Gamma Slide Test For Infectious Mononucleosis.
Device ID | K861016 |
510k Number | K861016 |
Device Name: | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS |
Classification | System, Test, Infectious Mononucleosis |
Applicant | GAMMA BIOLOGICALS, INC. 3700 MANGUM RD., #451-M Houston, TX 77092 -5497 |
Contact | John Case |
Correspondent | John Case GAMMA BIOLOGICALS, INC. 3700 MANGUM RD., #451-M Houston, TX 77092 -5497 |
Product Code | KTN |
CFR Regulation Number | 866.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-18 |
Decision Date | 1986-04-18 |