The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Seratest Ena [scl-70] Kit.
Device ID | K894411 |
510k Number | K894411 |
Device Name: | SERATEST ENA [SCL-70] KIT |
Classification | Antinuclear Antibody, Antigen, Control |
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 | LKJ |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-17 |
Decision Date | 1989-08-02 |