The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Micro Dau Cocaine Metabolite Test Kit.
Device ID | K896781 |
510k Number | K896781 |
Device Name: | MICRO DAU COCAINE METABOLITE TEST KIT |
Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | Francis E Capitanio |
Correspondent | Francis E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | DIO |
CFR Regulation Number | 862.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-04 |
Decision Date | 1990-03-23 |