K851573 is an FDA 510(k) clearance for the ABBOTT PHARAMACOKINETICS SYSTEMS. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 8, 1986, 266 days after receiving the submission on April 17, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K851573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1985 |
| Decision Date | January 08, 1986 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | NDC — Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |