The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Immunotech Cholesterol Test.
Device ID | K897036 |
510k Number | K897036 |
Device Name: | IMMUNOTECH CHOLESTEROL TEST |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
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 | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-18 |
Decision Date | 1990-03-06 |