The following data is part of a premarket notification filed by Scientific Research with the FDA for Agglutination Test For Total Ige.
| Device ID | K843369 |
| 510k Number | K843369 |
| Device Name: | AGGLUTINATION TEST FOR TOTAL IGE |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | SCIENTIFIC RESEARCH 1249 AMBLER Abilene , TX 79601 - |
| Contact | Swan |
| Correspondent | Swan SCIENTIFIC RESEARCH 1249 AMBLER Abilene , TX 79601 - |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-11-14 |