K831036 is an FDA 510(k) clearance for the ENA TEST KIT SM & RNP AUTO ANTIBODY. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983, 27 days after receiving the submission on March 31, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K831036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1983 |
| Decision Date | April 27, 1983 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |