K111999 is an FDA 510(k) clearance for the HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL. This device is classified as a Blood, Occult, Colorimetric, In Urine (Class II - Special Controls, product code JIO).
Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on April 17, 2012, 279 days after receiving the submission on July 13, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K111999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2011 |
| Decision Date | April 17, 2012 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIO — Blood, Occult, Colorimetric, In Urine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |