K844105 is an FDA 510(k) clearance for the FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY..
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 6, 1984, 44 days after receiving the submission on October 23, 1984.
This device falls under the Immunology FDA review panel.
| 510(k) Number | K844105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1984 |
| Decision Date | December 06, 1984 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | — |
| Device Class | — |