The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Assayed Control Serum Level 1 & 2.
| Device ID | K031101 |
| 510k Number | K031101 |
| Device Name: | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Jose Montanez |
| Correspondent | Jose Montanez HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238010585 | K031101 | 000 |
| 00817238010578 | K031101 | 000 |