K030775 is an FDA 510(k) clearance for the AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Immuno Concepts, N.A. , Ltd. (Dallas, US). The FDA issued a Cleared decision on May 12, 2003, 62 days after receiving the submission on March 11, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K030775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2003 |
| Decision Date | May 12, 2003 |
| Days to Decision | 62 days |
| Submission Type | Abbreviated |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKJ - Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |