The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme Phencyclidine Enzyme Immunoassay Test Kt.
Device ID | K911153 |
510k Number | K911153 |
Device Name: | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT |
Classification | Enzyme Immunoassay, Phencyclidine |
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 | LCM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-15 |
Decision Date | 1991-06-18 |