K781403 is an FDA 510(k) clearance for the FTA-ABS TEST SYSTEM. This device is classified as a Anti-human Globulin, Fta-abs Test (Class II - Special Controls, product code GMS).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1978, 6 days after receiving the submission on August 15, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K781403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1978 |
| Decision Date | August 21, 1978 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMS — Anti-human Globulin, Fta-abs Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |