K961815 is an FDA 510(k) clearance for the QUALITROL ANA CONTROL SERUM SET. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ).
Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on September 27, 1996, 140 days after receiving the submission on May 10, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K961815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | May 10, 1996 |
| Decision Date | September 27, 1996 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| 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 |