K905149 is an FDA 510(k) clearance for the TITAN GEL. This device is classified as a Gamma Globulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DAH).
Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 3, 1991, 49 days after receiving the submission on November 15, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K905149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1990 |
| Decision Date | January 03, 1991 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAH — Gamma Globulin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |