The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Enzygnost Tm Rubella Igm.
| Device ID | K813493 |
| 510k Number | K813493 |
| Device Name: | ENZYGNOST TM RUBELLA IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-14 |
| Decision Date | 1982-03-04 |