Submission Details
| 510(k) Number | K142280 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 15, 2014 |
| Decision Date | October 16, 2014 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
Oct 2014
Decision
62d
Days
Class 2
Risk
About This 510(k) Submission
K142280 is an FDA 510(k) clearance for the Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine 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 October 16, 2014, 62 days after receiving the submission on August 15, 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
Similar Devices — DJG Enzyme Immunoassay, Opiates
All 214
K252684 · Medtox Diagnostics, Inc.
· Jan 2026
K250741 · Randox Laboratories Limited
· Jan 2026
K253082 · Lin-Zhi International, Inc.
· Jan 2026
K252520 · Immunalysis Corporation
· Sep 2025
K251972 · Healgen Scientific, LLC
· Aug 2025
K251634 · Lin-Zhi International, Inc.
· Jun 2025
More from Healgen Scientific, LLC
View all
K252523
· NFW · Feb 2026
K251800
· JMT · Dec 2025
K253567
· NGL · Dec 2025
K251972
· DJG · Aug 2025
K243365
· NGL · Dec 2024