K843541 is an FDA 510(k) clearance for the PDA GLUCOSE. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 28, 1984, 21 days after receiving the submission on September 7, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K843541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1984 |
| Decision Date | September 28, 1984 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |