K811202 is an FDA 510(k) clearance for the ULTRACHEM GLUC-DH, ITEM NO. 65048. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981, 26 days after receiving the submission on May 1, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K811202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1981 |
| Decision Date | May 27, 1981 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |