Submission Details
| 510(k) Number | K111999 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Apr 2012
Decision
279d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 864.6550.
Device Classification
| Product Code | JIO — Blood, Occult, Colorimetric, In Urine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
Manufacturer
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