The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Cardiolipin Antibody Kit (eia Method0.
Device ID | K932373 |
510k Number | K932373 |
Device Name: | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 |
Classification | System, Test, Anticardiolipin Immunological |
Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Contact | Charles A Willand |
Correspondent | Charles A Willand HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Product Code | MID |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-17 |
Decision Date | 1993-07-16 |