K935675 is an FDA 510(k) clearance for the AXSYM PROLACTIN. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994, 207 days after receiving the submission on November 26, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.
| 510(k) Number | K935675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1993 |
| Decision Date | June 21, 1994 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFT — Radioimmunoassay, Prolactin (lactogen) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1625 |