The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Cholylglycine Enzyme Immuno. Kit.
| Device ID | K803296 |
| 510k Number | K803296 |
| Device Name: | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT |
| Classification | Radioimmunoassay, Cholyglycine, Bile Acids |
| Applicant | IMMUNOTECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWW |
| CFR Regulation Number | 862.1177 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-01-16 |