K053253 is an FDA 510(k) clearance for the HEMOCUE ALBUMIN 201 ANALYZING SYSTEM. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on February 17, 2006, 88 days after receiving the submission on November 21, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K053253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2005 |
| Decision Date | February 17, 2006 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQO - Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |