Submission Details
| 510(k) Number | K141647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 19, 2014 |
| Decision Date | July 17, 2014 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
Jul 2014
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K141647 is an FDA 510(k) clearance for the HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD), a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Healgen Scientific, LLC (Gaithersburg, US). The FDA issued a Cleared decision on July 17, 2014, 28 days after receiving the submission on June 19, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3250.
Device Classification
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3250 |
Manufacturer
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