The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Acl Iga Calibrator.
Device ID | K941840 |
510k Number | K941840 |
Device Name: | HEMAGEN ACL IGA CALIBRATOR |
Classification | System, Test, Anticardiolipin Immunological |
Applicant | HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
Contact | Joseph M Califano |
Correspondent | Joseph M Califano HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, 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 | 1994-04-13 |
Decision Date | 1994-06-30 |