The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Cmv Igg Kit.
Device ID | K944438 |
510k Number | K944438 |
Device Name: | HEMAGEN CMV IGG KIT |
Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Contact | Joseph M Califano |
Correspondent | Joseph M Califano HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Product Code | LFZ |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-12 |
Decision Date | 1997-02-20 |
Summary: | summary |