K802299 is an FDA 510(k) clearance for the K/K (ASMA/ANA) UNIVERSAL BIOPAK. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DHN).
Submitted by Bioware Products (Mchenry, US). The FDA issued a Cleared decision on January 29, 1981, 132 days after receiving the submission on September 19, 1980.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K802299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1980 |
| Decision Date | January 29, 1981 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |