K842522 is an FDA 510(k) clearance for the PDA SYSTEM. This device is classified as a Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I - General Controls, product code JJG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 2, 1984, 36 days after receiving the submission on June 27, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2140.
| 510(k) Number | K842522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1984 |
| Decision Date | August 02, 1984 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2140 |