K811263 is an FDA 510(k) clearance for the TOX TM ANALYZER. This device is classified as a Polarimeter (Class I - General Controls, product code JQZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 29, 1981, 23 days after receiving the submission on May 6, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K811263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1981 |
| Decision Date | May 29, 1981 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JQZ — Polarimeter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |