The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme(tm) Methamphet/amphet Enzyme Immuno Kit.
Device ID | K903993 |
510k Number | K903993 |
Device Name: | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT |
Classification | Enzyme Immunoassay, Amphetamine |
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 | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-29 |
Decision Date | 1990-12-20 |