The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Analyst Panels + Analytical Test Rotor.
Device ID | K010864 |
510k Number | K010864 |
Device Name: | ANALYST PANELS + ANALYTICAL TEST ROTOR |
Classification | Enzymatic, Carbon-dioxide |
Applicant | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
Contact | Jose A Montanez |
Correspondent | Jose A Montanez HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
Product Code | KHS |
Subsequent Product Code | CEO |
Subsequent Product Code | CIG |
Subsequent Product Code | CIX |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-22 |
Decision Date | 2001-05-21 |