K771129 is an FDA 510(k) clearance for the AUTO-LOGIC II SYSTEM. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 4, 1977, 42 days after receiving the submission on June 23, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K771129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1977 |
| Decision Date | August 04, 1977 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJJ — Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |