The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen C-reactive Protein Kit (eia Method).
Device ID | K944288 |
510k Number | K944288 |
Device Name: | HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) |
Classification | C-reactive Protein, Antigen, Antiserum, And Control |
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 | DCK |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-02 |
Decision Date | 1994-10-03 |