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 |