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 |