The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Immunotech Hdl-cholesterol Test.
Device ID | K900036 |
510k Number | K900036 |
Device Name: | IMMUNOTECH HDL-CHOLESTEROL TEST |
Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | E Capitanio |
Correspondent | E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | LBS |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-02 |
Decision Date | 1990-03-09 |