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 |