The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Phenobarbital.
| Device ID | K852995 |
| 510k Number | K852995 |
| Device Name: | ENDAB PHENOBARBITAL |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Contact | John H Carter |
| Correspondent | John H Carter IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-08-12 |