The following data is part of a premarket notification filed by Gelco Diagnostics, Inc. with the FDA for Goat Anti-human Kappa Affinity.
| Device ID | K832260 |
| 510k Number | K832260 |
| Device Name: | GOAT ANTI-HUMAN KAPPA AFFINITY |
| Classification | Kappa, Fitc, Antigen, Antiserum, Control |
| Applicant | GELCO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DEO |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-30 |
| Decision Date | 1983-10-31 |