The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Ena Test Kit Sm & Rnp Auto Antibody.
| Device ID | K831036 |
| 510k Number | K831036 |
| Device Name: | ENA TEST KIT SM & RNP AUTO ANTIBODY |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-31 |
| Decision Date | 1983-04-27 |