The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Immunoglobulin M Reagent System.
| Device ID | K800167 |
| 510k Number | K800167 |
| Device Name: | IMMUNOGLOBULIN M REAGENT SYSTEM |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-25 |
| Decision Date | 1980-02-05 |