The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Test, Latex Slide, Rheumatoid Factor.
| Device ID | K760036 |
| 510k Number | K760036 |
| Device Name: | TEST, LATEX SLIDE, RHEUMATOID FACTOR |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | GAMMA BIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-14 |
| Decision Date | 1976-08-03 |