Submission Details
| 510(k) Number | K143187 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 2014 |
| Decision Date | January 27, 2015 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
Jan 2015
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K143187 is an FDA 510(k) clearance for the Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on January 27, 2015, 83 days after receiving the submission on November 5, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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