The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantitope 125i-folate Radioassay Kit.
| Device ID | K780508 |
| 510k Number | K780508 |
| Device Name: | QUANTITOPE 125I-FOLATE RADIOASSAY KIT |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-30 |
| Decision Date | 1978-05-03 |