The following data is part of a premarket notification filed by Amtec Diagnostics International, Inc. with the FDA for Amtec Rheumatoid Factor Latex Agglutination Kit.
| Device ID | K873064 |
| 510k Number | K873064 |
| Device Name: | AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | AMTEC DIAGNOSTICS INTERNATIONAL, INC. 1107 IH-45 SOUTH P.O. BOX 2968 Conroe, TX 77305 |
| Contact | Helen Johnson |
| Correspondent | Helen Johnson AMTEC DIAGNOSTICS INTERNATIONAL, INC. 1107 IH-45 SOUTH P.O. BOX 2968 Conroe, TX 77305 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-05 |
| Decision Date | 1987-11-04 |