K772084 is an FDA 510(k) clearance for the LAS-R HUMAN C3 PROACTIVATOR TEST. This device is classified as a Factor B, Antigen, Antiserum, Control (Class II - Special Controls, product code JZH).
Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 24, 1978, 81 days after receiving the submission on November 4, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5320.
| 510(k) Number | K772084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1977 |
| Decision Date | January 24, 1978 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZH — Factor B, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5320 |