K830688 is an FDA 510(k) clearance for the COMBION SKIN TEST. This device is classified as a Antisera, Immunoperoxidase, Chlamydia Spp. (Class I - General Controls, product code LKH).
Submitted by Nicholas H. Maganias (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983, 27 days after receiving the submission on March 4, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K830688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1983 |
| Decision Date | March 31, 1983 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LKH — Antisera, Immunoperoxidase, Chlamydia Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |